AU1993395A – Use of complex carbohydrate to diminish hypoglycemia in patients with diabetes mellitus
– Google Patents
AU1993395A – Use of complex carbohydrate to diminish hypoglycemia in patients with diabetes mellitus
– Google Patents
Use of complex carbohydrate to diminish hypoglycemia in patients with diabetes mellitus
Info
Publication number
AU1993395A
AU1993395A
AU19933/95A
AU1993395A
AU1993395A
AU 1993395 A
AU1993395 A
AU 1993395A
AU 19933/95 A
AU19933/95 A
AU 19933/95A
AU 1993395 A
AU1993395 A
AU 1993395A
AU 1993395 A
AU1993395 A
AU 1993395A
Authority
AU
Australia
Prior art keywords
carbohydrate
hypoglycemia
patients
cornstarch
uncooked cornstarch
Prior art date
1994-03-15
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
AU19933/95A
Other versions
AU690654B2
(en
Inventor
Francine Kaufman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Childrens Hospital Los Angeles
Original Assignee
Childrens Hospital Los Angeles
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
1994-03-15
Filing date
1995-03-14
Publication date
1995-10-03
1995-03-14
Application filed by Childrens Hospital Los Angeles
filed
Critical
Childrens Hospital Los Angeles
1995-10-03
Publication of AU1993395A
publication
Critical
patent/AU1993395A/en
1998-04-30
Application granted
granted
Critical
1998-04-30
Publication of AU690654B2
publication
Critical
patent/AU690654B2/en
2015-03-14
Anticipated expiration
legal-status
Critical
Status
Ceased
legal-status
Critical
Current
Links
Espacenet
Global Dossier
Discuss
150000001720
carbohydrates
Chemical class
0.000
title
claims
description
37
206010012601
diabetes mellitus
Diseases
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title
claims
description
19
230000002218
hypoglycaemic effect
Effects
0.000
title
description
30
208000013016
Hypoglycemia
Diseases
0.000
title
description
28
229920002261
Corn starch
Polymers
0.000
claims
description
38
239000008120
corn starch
Substances
0.000
claims
description
38
229940099112
cornstarch
Drugs
0.000
claims
description
38
235000014633
carbohydrates
Nutrition
0.000
claims
description
36
239000008280
blood
Substances
0.000
claims
description
33
210000004369
blood
Anatomy
0.000
claims
description
33
NOESYZHRGYRDHS-UHFFFAOYSA-N
insulin
Chemical compound
N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1
NOESYZHRGYRDHS-UHFFFAOYSA-N
0.000
claims
description
28
WQZGKKKJIJFFOK-GASJEMHNSA-N
Glucose
Natural products
OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O
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glucose
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method
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snacks
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claims
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102000004877
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14
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14
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insulin
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claims
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14
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body weight
Effects
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claims
description
6
238000007920
subcutaneous administration
Methods
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claims
description
5
238000000576
coating method
Methods
0.000
claims
description
3
235000003599
food sweetener
Nutrition
0.000
claims
description
3
239000003765
sweetening agent
Substances
0.000
claims
description
3
239000011248
coating agent
Substances
0.000
claims
description
2
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pharmaceutical composition
Substances
0.000
claims
description
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238000002360
preparation method
Methods
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claims
description
2
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regulatory effect
Effects
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claims
description
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sustained release
Methods
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claims
description
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sustained-release form
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claims
description
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therapeutic procedure
Methods
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claims
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Homo
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claims
1
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liquid
Substances
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claims
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stabilizing effect
Effects
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claims
1
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symptom
Diseases
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description
8
238000009472
formulation
Methods
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description
5
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mixture
Substances
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description
5
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treatment
Methods
0.000
description
5
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hyperglycemia
Diseases
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description
4
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milk
Nutrition
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description
4
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milk
Substances
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description
4
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milk
Anatomy
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description
4
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Convulsion
Diseases
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description
3
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Pancrelipase
Proteins
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description
3
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Type 1 diabetes mellitus
Diseases
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description
3
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breakfast
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description
3
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convulsion
Effects
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description
3
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food intake
Effects
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description
3
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metabolic process
Effects
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description
3
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sleep
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description
3
239000003826
tablet
Substances
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description
3
UCTWMZQNUQWSLP-VIFPVBQESA-N
(R)-adrenaline
Chemical compound
CNC[C@H](O)C1=CC=C(O)C(O)=C1
UCTWMZQNUQWSLP-VIFPVBQESA-N
0.000
description
2
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(R)-adrenaline
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2
208000003443
Unconsciousness
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239000011230
binding agent
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description
2
238000006243
chemical reaction
Methods
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description
2
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decrease
Effects
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description
2
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disease
Diseases
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description
2
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diseases, disorders, signs and symptoms
Diseases
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description
2
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effects
Effects
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description
2
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epinephrine
Drugs
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description
2
201000004541
glycogen storage disease I
Diseases
0.000
description
2
239000004615
ingredient
Substances
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description
2
230000007774
longterm
Effects
0.000
description
2
239000007937
lozenge
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description
2
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modification
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230000004048
modification
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nervous system symptom
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nocturnal effect
Effects
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testing method
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type 2 diabetes mellitus
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1
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Anxiety disease
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1
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Diabetes Complications
Diseases
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description
1
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Glycogen
Polymers
0.000
description
1
208000032003
Glycogen storage disease due to glucose-6-phosphatase deficiency
Diseases
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description
1
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Headaches
Diseases
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description
1
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Hyperhidrosis
Diseases
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1
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Student’s t-test
Methods
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1
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Tachycardia
Diseases
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description
1
206010044565
Tremor
Diseases
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description
1
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absorption reaction
Methods
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description
1
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accumulation
Methods
0.000
description
1
230000001800
adrenalinergic effect
Effects
0.000
description
1
230000036506
anxiety
Effects
0.000
description
1
-1
bread
Chemical class
0.000
description
1
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bread
Nutrition
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1
239000002775
capsule
Substances
0.000
description
1
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central nervous system
Anatomy
0.000
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1
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cereals
Nutrition
0.000
description
1
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delay
Effects
0.000
description
1
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development
Methods
0.000
description
1
230000029087
digestion
Effects
0.000
description
1
208000002173
dizziness
Diseases
0.000
description
1
239000002552
dosage form
Substances
0.000
description
1
229940079593
drug
Drugs
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description
1
239000003814
drug
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0.000
description
1
230000002124
endocrine
Effects
0.000
description
1
235000013305
food
Nutrition
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description
1
230000002641
glycemic effect
Effects
0.000
description
1
229940096919
glycogen
Drugs
0.000
description
1
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glycogen storage disease
Diseases
0.000
description
1
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headache
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description
1
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hunger
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0.000
description
1
239000007924
injection
Substances
0.000
description
1
238000002347
injection
Methods
0.000
description
1
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intestine
Anatomy
0.000
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1
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kidney
Anatomy
0.000
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1
210000004185
liver
Anatomy
0.000
description
1
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material
Substances
0.000
description
1
230000003340
mental effect
Effects
0.000
description
1
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monitoring process
Methods
0.000
description
1
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monosaccharides
Chemical class
0.000
description
1
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neuropathic effect
Effects
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description
1
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nutrition
Nutrition
0.000
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1
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orange juice
Nutrition
0.000
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1
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organ
Anatomy
0.000
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pill
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postprandial effect
Effects
0.000
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proteins and genes
Human genes
0.000
description
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proteins and genes
Proteins
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description
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recurrent effect
Effects
0.000
description
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retinal effect
Effects
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description
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sleep time
Effects
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description
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statistical method
Methods
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description
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sustained release tablet
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sweating
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syrup
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syrup
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tachycardia
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Classifications
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
A23G3/368—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing vitamins, antibiotics
A—HUMAN NECESSITIES
A21—BAKING; EDIBLE DOUGHS
A21D—TREATMENT, e.g. PRESERVATION, OF FLOUR OR DOUGH, e.g. BY ADDITION OF MATERIALS; BAKING; BAKERY PRODUCTS; PRESERVATION THEREOF
A21D2/00—Treatment of flour or dough by adding materials thereto before or during baking
A21D2/08—Treatment of flour or dough by adding materials thereto before or during baking by adding organic substances
A21D2/14—Organic oxygen compounds
A21D2/16—Fatty acid esters
A—HUMAN NECESSITIES
A21—BAKING; EDIBLE DOUGHS
A21D—TREATMENT, e.g. PRESERVATION, OF FLOUR OR DOUGH, e.g. BY ADDITION OF MATERIALS; BAKING; BAKERY PRODUCTS; PRESERVATION THEREOF
A21D2/00—Treatment of flour or dough by adding materials thereto before or during baking
A21D2/08—Treatment of flour or dough by adding materials thereto before or during baking by adding organic substances
A21D2/14—Organic oxygen compounds
A21D2/18—Carbohydrates
A21D2/186—Starches; Derivatives thereof
A—HUMAN NECESSITIES
A21—BAKING; EDIBLE DOUGHS
A21D—TREATMENT, e.g. PRESERVATION, OF FLOUR OR DOUGH, e.g. BY ADDITION OF MATERIALS; BAKING; BAKERY PRODUCTS; PRESERVATION THEREOF
A21D2/00—Treatment of flour or dough by adding materials thereto before or during baking
A21D2/08—Treatment of flour or dough by adding materials thereto before or during baking by adding organic substances
A21D2/24—Organic nitrogen compounds
A21D2/26—Proteins
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L25/00—Food consisting mainly of nutmeat or seeds; Preparation or treatment thereof
A23L25/30—Mashed or comminuted products, e.g. pulp, pastes, meal, powders; Products made therefrom, e.g. blocks, flakes, snacks; Liquid or semi-liquid products
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
A23L29/212—Starch; Modified starch; Starch derivatives, e.g. esters or ethers
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
A23L33/115—Fatty acids or derivatives thereof; Fats or oils
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
A23L33/17—Amino acids, peptides or proteins
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
A23L7/10—Cereal-derived products
A23L7/117—Flakes or other shapes of ready-to-eat type; Semi-finished or partly-finished products therefor
A23L7/126—Snacks or the like obtained by binding, shaping or compacting together cereal grains or cereal pieces, e.g. cereal bars
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
A23L9/00—Puddings; Cream substitutes; Preparation or treatment thereof
A23L9/10—Puddings; Dry powder puddings
A23L9/12—Ready-to-eat liquid or semi-liquid desserts, e.g. puddings, not to be mixed with liquids, e.g. water, milk
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
A61K31/00—Medicinal preparations containing organic active ingredients
A61K31/70—Carbohydrates; Sugars; Derivatives thereof
A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
A61P3/00—Drugs for disorders of the metabolism
A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
A61P3/00—Drugs for disorders of the metabolism
A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
A—HUMAN NECESSITIES
A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Description
USE OF COMPLEX CARBOHYDRATE TO DIMINISH HYPOGLYCEMIA IN PATIENTS WITH DIABETES MELLITUS
BACKGROUND OF THE INVENTION
1. Field of the Invention This invention relates to therapeutic treatments of diabetes mellitus. More particularly, this invention relates to the use of uncooked cornstarch in the treatment of hypoglycemia caused by Type I and Type II diabetes mellitus.
2. Description of Related Art Symptoms of hypoglycemia fall into two main categories. Rapid epinephrine release causes sweating, tremor, tachycardia, anxiety, and hunger. Central nervous system symptoms include dizziness, headache, clouding of vision, blunted mental acuity, confusion, abnormal behavior, convulsions, and loss of consciousness. When hypoglycemia is recurrent or severe, nervous system symptoms predominate, and the epinephrine phase may not be recognizable. With more rapid drops or wide swings in plasma glucose (as in insulin reactions), adrenergic symptoms are prominent (Harrison’s Principles of Internal Medicine, 11th Ed., McGraw-Hill Book Company, New York, 1987, p. 1800).
Numerous strategies have been developed to achieve the goal of maintaining blood glucose at a relatively constant level, such as open looped continuous subcutaneous insulin pumps and multiple daily injections of insulin. These intensive insulin regimens are coupled with home glucose monitoring, and many patients measure their blood
glucose levels by finger prick up to 6 to 8 times per day to assure that close to normal blood sugar levels are maintained. This regimen is prescribed because studies have shown that by avoiding excessive high blood sugar levels, the long-term outcome of patients with diabetes can be improved. However, this regimen, which decreases episodes of high blood sugar, also causes patients to experience more low blood sugar reactions (hypoglycemia). Results of the Diabetes Complication and Control Trial indicate that intensive insulin treatment, while it markedly delays and lessens long term retinal, nephrologic and neuropathic disease, leads to a three to nine-fold increase in hypoglycemic events, most of which occur at night (L.Y. Dawson, Clinical Diabetes, 11:88-96, 1993). Sometimes these episodes of hypoglycemia are severe and can lead to loss of consciousness and convulsions. Severe hypoglycemic events seem to occur more often at night while the patient is asleep rather than during the day. When awake, diabetic patients can feel hypoglycemic reactions beginning, and can treat themselves with sugar in order to bring their blood sugar levels back into the normal range. When asleep, patients do not have this awareness, therefore the risk of hypoglycemic is much higher during this time.
The need exists to develop strategies to diminish hypoglycemia while continuing to intensively manage diabetes. Cornstarch has been used effectively to combat the hypoglycemia associated with glycogen storage disease type 1, a disease having an inherited absence or deficiency of glucose-6-phosphatase activity in the liver, kidney, and intestines, leading to accumulation of glycogen in those organs and hypoglycemia during fasting. Protection against low blood sugar was provided for up to 6 to 8 hours after ingestion of uncooked cornstarch
(J. I. Wolfsdorf, et al., Am. J. Clin. Nutr., 52:1051-7, 1990). However, the dosage of cornstarch used for this treatment was 1.75 grams per kilogram of body weight. This dosage is much higher than could be tolerated by a patient with diabetes mellitus.
Another study has also been conducted in patients with diabetes, giving cornstarch during inpatient hospitalization, with a reduction in the nadir of the blood glucose level. Children were fasted and then given the entire carbohydrate content of the standard bedtime snack (30 grams of carbohydrate) as uncooked cornstarch (M.T. Ververs, et al., Bur. J. Clin. Nutr., 47:268-73, 1983). However, this study did little to prevent hypoglycemia and did not evaluate varying dosages to determine maximal efficacy.
Thus, the need exists for a better method of treating hypoglycemia in diabetics whether it results from too large a dose of insulin in patients with Type II diabetes who use insulin, or whether it occurs in patients with Type I diabetes, such as in pediatric patients during sleep.
SUMMARY OF THE INVENTION
Blood glucose levels in patients with Diabetes Mellitus is regulated and stabilized by ingesting a complex carbohydrate, preferably uncooked cornstarch, in the dose of about 0.1 to 1.0 gram per kilogram of body weight.
A pharmaceutical composition being a preparation of a unit dose of uncooked cornstarch is also provided.
A DETAILED DESCRIPTION OF THE INVENTION
This study will attempt to determine if uncooked cornstarch, given in a dose of 1.0 gram per kilo added to milk (equivalent to 25-50% of the evening snack carbohydrate calories) can diminish the incidence and severity of hypoglycemia in hospitalized patients receiving subcutaneous insulin and in outpatients while on their usual insulin regimens.
This invention provides a method of utilizing complex carbohydrates, and in particular, uncooked cornstarch, to stabilize glucose levels in patients by titrating the dosage so as to avoid both hyper- and hypoglycemia, for in diabetics hyperglycemia can be caused by ingestion of too much carbohydrate. In particular, this invention provides a method for administering to a diabetic patient a measured dose of complex carbohydrate, preferably in the form of uncooked cornstarch, to stabilize blood sugar levels above that generally identified with the onset of clinical symptoms of hypoglycemia. The definition of the onset of clinical symptoms of hypoglycemia as used herein is a blood glucose level less than or equal to 3.0 mmol/liter or 60 mg/deciliter of whole blood.
In the practice of this invention, uncooked cornstarch is the preferred source of complex carbohydrate since its carbohydrate content is relatively uniform, its rate of metabolism is both known and uniform, and can be readily formulated into easy to administer tablets, syrups (sweetened with synthetic sweeteners), coatings, etc.
Diabetic patients cannot tolerate the high dosage of uncooked cornstarch used in the treatment of glycogen storage disease without developing hyperglycemia. The preferred dose of complex carbohydrate administered to a diabetic patient to forestall development of the clinical symptoms of hypoglycemia is, therefore, much lower, about 0.1 to 1.0 gram per kilogram, more preferably about 0.25 to 0.5 grams per kilogram of body weight.
In addition, in children under the age of two years, it is also preferred that the dosage of complex carbohydrate be administered together with the enzyme pancrease in an amount useful to promote digestion of complex carbohydrate. The pancrease is given adjunctively, usually in a dosage of about 1/4 teaspoon of pancrease per dose of complex carbohydrate.
All patients taking insulin to facilitate post-prandial absorption of glucose can be treated recurrently during the day with premeasured doses of complex carbohydrate that is slowly metabolized to the monosaccharide glucose over a period of six to eight hours instead of being treated with simple carbohydrates, such as orange juice or other sugar sources that tend to cause a rapid peak in blood glucose level that quickly subsides. During waking hours the patient’s use of, and hence requirement for, glucose is varied and depends upon the level and type of activity. The exact amount and frequency of the actual dose, therefore, will vary by patient and from day to day for each patient. A blood glucose test, usually administered as a finger prick to obtain a blood sample, can be used to monitor daily glucose levels as well as the patient’s own subjective experience of symptoms associated with the onset of hypoglycemia. Therefore, in the practice
of this invention sufficient complex carbohydrate is administered, preferably in the form of uncooked cornstarch, to maintain the blood glucose level somewhat above this level.
To prevent hypoglycemia during overnight sleep periods, the complex carbohydrate is administered to the patient at bedtime, and the above described dose of uncooked cornstarch is sufficient so the patient passes the nocturnal sleep time without need for glucose intervention and awakens after about six to eight hours of sleep with a glucose level of 60 mg/dl or greater. Many diabetics routinely consume a standard bedtime snack containing about 30 grams of carbohydrate, such as bread, or cereal and milk. In the practice of this invention, about 1/4 to 1//2 of the bedtime carbohydrate snack is replaced by uncooked cornstarch to stabilize blood sugar levels through the night (for six to eight hours) and to wear off in time for the patient to awaken with a normal blood sugar level.
For convenience in measuring the dosage actually consumed, it is preferred that the complex carbohydrate be prepared in unit dosage forms of 5 grams each. The unit dosage can be formulated as tablets, lozenges, capsules, and the like, using techniques well known in the art. To assure proper metabolism of the complex carbohydrate, it is also preferred that the it be consumed together with at least two other food exchanges selected from the group consisting of fat, protein and other carbohydrates. For instance, cornstarch is routinely used as a binder in formulation of tablets (see Remington’s Pharmaceutical Sciences, 18th Edition, Mack Publishing Company, 1990, pp. 1633- 1675). It is preferred that ingredients in addition to uncooked
cornstarch used in the formulation be inert to metabolism, such as cellulosic binders and the like, or, if not inert, that the nutritional contribution of such formulation ingredients to the carbohydrate content of the unit dosage be taken into account in formulating the unit dosage. In an alternative embodiment, the unit dosage formulations of complex carbohydrate used in the practice of the method of this invention are in the form of sustained release tablets, pills, lozenges, and the like. Sustained release formulations can be prepared in the 5 gram unit dose form using techniques well known in the art (Remington’s Pharmaceutical Sciences, supra, pp 1676-1686. In yet another embodiment of this invention, the uncooked cornstarch is incorporated into a snack bar containing a total of about 30 grams of carbohydrate (comparable to prior art bedtime snacks for diabetics), but having about 1/2 to 1/4 of the carbohydrate in the snack be uncooked cornstarch in the form of a filling or coating, for example, one sweetened with a non-sugar sweetener.
The following examples illustrate the manner in which the invention can be practiced. It is understood, however, that the examples are for the purpose of illustration and the invention is not to be regarded as limited to any of the specific materials or conditions therein.
EXAMPLE 1
Forty patients with Type I Diabetes Mellitus who were receiving subcutaneous insulin hospitalized at Children’s Hospital of Los Angeles or were seen in the Endocrine Outpatient Clinic and were receiving their usual insulin regimens were asked to participate in a study to determine whether administration of uncooked cornstarch
as part of the evening snack would diminish the incidence and severity of hypoglycemia. On day one, ten patients, 2 to 25 years of age were treated as inpatients and patients received 1.0 gram/kg of body weight of uncooked cornstarch (Arrow Cornstarch) in milk as part of the bedtime snack. Hourly bedside blood glucose determinations were done from midnight until 6 a.m. by fingerstick requiring a single drop of blood. In addition, observable symptoms of hypoglycemia, such as thrashing about or convulsions were recorded. If significant hyperglycemia was experienced, the dosage of uncooked cornstarch for day two was reduced to 0.5 g/kg. If on the other hand, significant hypoglycemia was experienced, on day two the dose was increased to 1.5 grams/kg. In addition, an oral report of the patient’s observable nighttime symptoms was made either by the patient or its parent to an attending physician at least three times per week to monitor the patient’s progress on the study. Data was compared to inpatient records for the last two years and matched by age, sex and duration of diabetes.
Patients treated as inpatients of Children’s Hospital Los Angeles has a significant reduction in middle of the night hypoglycemia while receiving the cornstarch-containing snack compared to the regular snack. There was no significant elevation of the blood glucose lever after ingestion of the cornstarch-containing snack as would be seen with simple carbohydrates.
Thirty patients, 2 to 25 years of age, were tested as outpatients. Blood sugar tests were conducted prior to bed, at 2 to 3 a.m., and in the morning when awakened. The three blood sugar level readings were recorded for a two week period during which the patient received the
standard bedtime snack containing 30 grams of carbohydrate containing no cornstarch. During the following two week period, the same regimen was followed except that 25 to 50% of the carbohydrate portion of the evening snack administered at bedtime was uncooked cornstarch. Once again blood sugar levels were measured and recorded just prior to bed, at 2 to 3 a.m., and in the morning when awakened.
Blood glucose levels obtained during the first two week period were compared with those obtained during the second two week period. Statistical analysis will be performed with student t-test for inter and intra group comparisons for both blood sugar levels and incidence of symptomatic hypoglycemic events.
EXAMPLE 2
Twenty patients with a history of nighttime hypoglycemia, ages 5-16 years, and having had diabetes mellitus for more than one year, participated in the following study. For the first two week period the patients received the standard bedtime snack containing 30 grams of carbohydrate but no uncooked cornstarch. Blood glucose readings were done at 2 a.m. and before breakfast, with an at home glucose meter. During the second two week period, 1/4 to 1/2 of the carbohydrate content of the bedtime snack for each patient was given as uncooked cornstarch in milk. In Table 1 below the mean
(±SD) number of hypoglycemic episodes for the 13 subjects (as characterized by a blood glucose reading less than 60 mg/dl) are shown for the 2 a.m. reading and the before breakfast readings..
TABLE 1
14 days Standard 14 days Cornstarch
2 a.m. 2.00 ± 2.12 0.61 ± 0.87 before breakfast 2.61 ± 2.25 0.69 ± 1.03
Our results suggest that uncooked cornstarch can be used to decrease episodes of nocturnal hypoglycemia in young patients with diabetes mellitus and history of hypoglycemia. This was accomplished without increasing the mean AM blood glucose level, therefore not altering overall glycemic control.
The foregoing description of the invention is exemplary for purposes of illustration and explanation. It should be understood that various modifications can be made without departing from the spirit and scope of the invention. Accordingly, the following claims are intended to be interpreted to embrace all such modifications.
Claims (13)
1. A method for regulating and stabilizing blood glucose levels in humans with Diabetes Mellitus comprising ingesting a complex carbohydrate in the dose of about 0.1 to 1.0 gram per kilogram of body weight.
2. The method of claim 1 wherein the complex carbohydrate is uncooked cornstarch, said uncooked cornstarch being administered in a palatable carrier.
3. The method of claim 2 wherein the dose is from about 0.25 to 0.5 grams per kilogram of body weight.
4. The method of claim 1 wherein the Diabetes Mellitus is Type I and the human further receives a regimen of subcutaneous insulin therapy.
5. The method of claim 1 wherein the Diabetes Mellitus is Type II and the human further receives a regimen of subcutaneous insulin therapy.
6. The method of claim 1 wherein the carrier is a liquid.
7. The method of claim 2 wherein the human receives a bedtime snack containing 30 grams of carbohydrate and the uncooked cornstarch is substituted for from 1/4 to 1/2 of the carbohydrate contained therein.
8. The method of claim 7 wherein the uncooked cornstarch is contained within a filling for or coating upon the bedtime snack and is sweetened with a non-sugar sweetener.
9. The method of claim 2 wherein the uncooked cornstarch is formulated in 5 gram unit doses.
10. The method of claim 9 wherein the unit doses are formulated for sustained release.
11. The method of claim 1 wherein the blood glucose level is stabilized to 60 mg/dl or greater for at least six hours.
12. The method of claim 2 wherein the blood glucose level is stabilized to 60 mg/dl or greater for at least six hours.
13. A pharmaceutical composition being a unit dose preparation of uncooked cornstarch.
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