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Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

Primary Purpose

Type 2 Diabetes, Metabolic Syndrome

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
water, glucose with or without amino acid
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes focused on measuring Glycemic Index, LoBAG Diet, Insulin, Glucagon

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects with or without type 2 diabetes
  • C-Peptide > 1.5 ng/ml
  • Able to come to the Minneapolis VA Medical Center on several occasions over 2-4 weeks

Exclusion Criteria:

  • Body mass index > 40
  • hematologic abnormalities
  • liver disease
  • kidney disease
  • congestive heart failure
  • life threatening malignancies

Sites / Locations

  • Minneapolis VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

glucose

Amino acid

amino acid plus glucose

Arm Description

240 ml water

50 g glucose

1 mmol amino acid/kg lean body mass

50 g glucose plus 1 mmol amino acid/kg lean body mass

Outcomes

Primary Outcome Measures

Change in blood glucose concentration
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.

Secondary Outcome Measures

Change in serum insulin concentration
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.

Full Information

First Posted
November 10, 2011
Last Updated
November 6, 2017
Sponsor
Minneapolis Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01471509
Brief Title
Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
Official Title
The Effect of Ingestion of Foods on the Plasma Glucose and Insulin Response in Subjects With Type 2 Diabetes: Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Suspended
Why Stopped
Lack of funding
Study Start Date
August 1982 (undefined)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 6, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.
Detailed Description
Various foods or food substances are given as a test meal. The metabolic response is determined at various times after the administration of the meal (e.g. blood glucose, and other hormones and metabolites).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Metabolic Syndrome
Keywords
Glycemic Index, LoBAG Diet, Insulin, Glucagon

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
240 ml water
Arm Title
glucose
Arm Type
Active Comparator
Arm Description
50 g glucose
Arm Title
Amino acid
Arm Type
Active Comparator
Arm Description
1 mmol amino acid/kg lean body mass
Arm Title
amino acid plus glucose
Arm Type
Active Comparator
Arm Description
50 g glucose plus 1 mmol amino acid/kg lean body mass
Intervention Type
Other
Intervention Name(s)
water, glucose with or without amino acid
Other Intervention Name(s)
foods or food constituents
Intervention Description
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Primary Outcome Measure Information:
Title
Change in blood glucose concentration
Description
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
Time Frame
several time points after ingestion of test substance
Secondary Outcome Measure Information:
Title
Change in serum insulin concentration
Description
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
Time Frame
Several time points after ingestion of test substance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with or without type 2 diabetes C-Peptide > 1.5 ng/ml Able to come to the Minneapolis VA Medical Center on several occasions over 2-4 weeks Exclusion Criteria: Body mass index > 40 hematologic abnormalities liver disease kidney disease congestive heart failure life threatening malignancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Q Nuttall, M.D., Ph.D.
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23984046
Citation
Iverson JF, Gannon MC, Nuttall FQ. Ingestion of leucine + phenylalanine with glucose produces an additive effect on serum insulin but less than additive effect on plasma glucose. J Amino Acids. 2013;2013:964637. doi: 10.1155/2013/964637. Epub 2013 Jul 29.
Results Reference
background
PubMed Identifier
25120925
Citation
Iverson JF, Gannon MC, Nuttall FQ. Interaction of ingested leucine with glycine on insulin and glucose concentrations. J Amino Acids. 2014;2014:521941. doi: 10.1155/2014/521941. Epub 2014 Jul 10.
Results Reference
background
PubMed Identifier
6389060
Citation
Nuttall FQ, Mooradian AD, Gannon MC, Billington C, Krezowski P. Effect of protein ingestion on the glucose and insulin response to a standardized oral glucose load. Diabetes Care. 1984 Sep-Oct;7(5):465-70. doi: 10.2337/diacare.7.5.465.
Results Reference
result
PubMed Identifier
3900180
Citation
Nuttall FQ, Gannon MC, Wald JL, Ahmed M. Plasma glucose and insulin profiles in normal subjects ingesting diets of varying carbohydrate, fat, and protein content. J Am Coll Nutr. 1985;4(4):437-50. doi: 10.1080/07315724.1985.10720086.
Results Reference
result
PubMed Identifier
3538843
Citation
Krezowski PA, Nuttall FQ, Gannon MC, Bartosh NH. The effect of protein ingestion on the metabolic response to oral glucose in normal individuals. Am J Clin Nutr. 1986 Dec;44(6):847-56. doi: 10.1093/ajcn/44.6.847.
Results Reference
result
PubMed Identifier
3545955
Citation
Gannon MC, Nuttall FQ, Krezowski PA, Billington CJ, Parker S. The serum insulin and plasma glucose responses to milk and fruit products in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1986 Nov;29(11):784-91. doi: 10.1007/BF00873217.
Results Reference
result
PubMed Identifier
3556106
Citation
Krezowski PA, Nuttall FQ, Gannon MC, Billington CJ, Parker S. Insulin and glucose responses to various starch-containing foods in type II diabetic subjects. Diabetes Care. 1987 Mar-Apr;10(2):205-12. doi: 10.2337/diacare.10.2.205.
Results Reference
result
PubMed Identifier
3322731
Citation
Gannon MC, Nuttall FQ. Factors affecting interpretation of postprandial glucose and insulin areas. Diabetes Care. 1987 Nov-Dec;10(6):759-63. doi: 10.2337/diacare.10.6.759.
Results Reference
result
PubMed Identifier
3276480
Citation
Nuttall FQ, Gannon MC. Quantitative importance of dietary constituents other than glucose as insulin secretagogues in type II diabetes. Diabetes Care. 1988 Jan;11(1):72-6. doi: 10.2337/diacare.11.1.72.
Results Reference
result
PubMed Identifier
3054432
Citation
Gannon MC, Nuttall FQ, Neil BJ, Westphal SA. The insulin and glucose responses to meals of glucose plus various proteins in type II diabetic subjects. Metabolism. 1988 Nov;37(11):1081-8. doi: 10.1016/0026-0495(88)90072-8.
Results Reference
result
PubMed Identifier
2673694
Citation
Gannon MC, Nuttall FQ, Westphal SA, Neil BJ, Seaquist ER. Effects of dose of ingested glucose on plasma metabolite and hormone responses in type II diabetic subjects. Diabetes Care. 1989 Sep;12(8):544-52. doi: 10.2337/diacare.12.8.544.
Results Reference
result
PubMed Identifier
2195298
Citation
Nuttall FQ, Gannon MC. Metabolic response to egg white and cottage cheese protein in normal subjects. Metabolism. 1990 Jul;39(7):749-55. doi: 10.1016/0026-0495(90)90112-p.
Results Reference
result
PubMed Identifier
2197851
Citation
Westphal SA, Gannon MC, Nuttall FQ. Metabolic response to glucose ingested with various amounts of protein. Am J Clin Nutr. 1990 Aug;52(2):267-72. doi: 10.1093/ajcn/52.2.267.
Results Reference
result
PubMed Identifier
2209312
Citation
Gannon MC, Nuttall FQ. Quantitation of the glucose area response to a meal. Diabetes Care. 1990 Oct;13(10):1095-6. doi: 10.2337/diacare.13.10.1095a. No abstract available.
Results Reference
result
PubMed Identifier
1959475
Citation
Nuttall FQ, Gannon MC. Plasma glucose and insulin response to macronutrients in nondiabetic and NIDDM subjects. Diabetes Care. 1991 Sep;14(9):824-38. doi: 10.2337/diacare.14.9.824.
Results Reference
result
PubMed Identifier
1588830
Citation
Nuttall FQ, Gannon MC, Burmeister LA, Lane JT, Pyzdrowski KL. The metabolic response to various doses of fructose in type II diabetic subjects. Metabolism. 1992 May;41(5):510-7. doi: 10.1016/0026-0495(92)90210-2.
Results Reference
result
PubMed Identifier
1406301
Citation
Gannon MC, Nuttall FQ, Lane JT, Burmeister LA. Metabolic response to cottage cheese or egg white protein, with or without glucose, in type II diabetic subjects. Metabolism. 1992 Oct;41(10):1137-45. doi: 10.1016/0026-0495(92)90300-y.
Results Reference
result
PubMed Identifier
1460185
Citation
Khan MA, Gannon MC, Nuttall FQ. Glucose appearance rate following protein ingestion in normal subjects. J Am Coll Nutr. 1992 Dec;11(6):701-6. doi: 10.1080/07315724.1992.10718270.
Results Reference
result
PubMed Identifier
8325201
Citation
Gannon MC, Ercan N, Westphal SA, Nuttall FQ. Effect of added fat on plasma glucose and insulin response to ingested potato in individuals with NIDDM. Diabetes Care. 1993 Jun;16(6):874-80. doi: 10.2337/diacare.16.6.874.
Results Reference
result
PubMed Identifier
8294726
Citation
Ercan N, Nuttall FQ, Gannon MC, Lane JT, Burmeister LA, Westphal SA. Plasma glucose and insulin responses to bananas of varying ripeness in persons with noninsulin-dependent diabetes mellitus. J Am Coll Nutr. 1993 Dec;12(6):703-9. doi: 10.1080/07315724.1993.10718362.
Results Reference
result
PubMed Identifier
8246770
Citation
Ercan N, Nuttall FQ, Gannon MC, Redmon JB, Sheridan KJ. Effects of glucose, galactose, and lactose ingestion on the plasma glucose and insulin response in persons with non-insulin-dependent diabetes mellitus. Metabolism. 1993 Dec;42(12):1560-7. doi: 10.1016/0026-0495(93)90151-d.
Results Reference
result
PubMed Identifier
7882816
Citation
Ercan N, Gannon MC, Nuttall FQ. Effect of added fat on the plasma glucose and insulin response to ingested potato given in various combinations as two meals in normal individuals. Diabetes Care. 1994 Dec;17(12):1453-9. doi: 10.2337/diacare.17.12.1453.
Results Reference
result
PubMed Identifier
8609837
Citation
Gannon MC, Nuttall FQ, Lane JT, Fang S, Gupta V, Sandhofer CR. Effect of 24 hours of starvation on plasma glucose and insulin concentrations in subjects with untreated non-insulin-dependent diabetes mellitus. Metabolism. 1996 Apr;45(4):492-7. doi: 10.1016/s0026-0495(96)90225-5.
Results Reference
result
PubMed Identifier
9538964
Citation
Gannon MC, Nuttall FQ, Grant CT, Ercan-Fang S, Ercan-Fang N. Stimulation of insulin secretion by fructose ingested with protein in people with untreated type 2 diabetes. Diabetes Care. 1998 Jan;21(1):16-22. doi: 10.2337/diacare.21.1.16.
Results Reference
result
PubMed Identifier
9729567
Citation
Holtschlag DJ, Gannon MC, Nuttall FQ. State-space models of insulin and glucose responses to diets of varying nutrient content in men and women. J Appl Physiol (1985). 1998 Sep;85(3):935-45. doi: 10.1152/jappl.1998.85.3.935.
Results Reference
result
PubMed Identifier
9773720
Citation
Gannon MC, Nuttall FQ, Westphal SA, Fang S, Ercan-Fang N. Acute metabolic response to high-carbohydrate, high-starch meals compared with moderate-carbohydrate, low-starch meals in subjects with type 2 diabetes. Diabetes Care. 1998 Oct;21(10):1619-26. doi: 10.2337/diacare.21.10.1619.
Results Reference
result
PubMed Identifier
11145118
Citation
Nuttall FQ, Khan MA, Gannon MC. Peripheral glucose appearance rate following fructose ingestion in normal subjects. Metabolism. 2000 Dec;49(12):1565-71. doi: 10.1053/meta.2000.18553.
Results Reference
result
PubMed Identifier
11172481
Citation
Gannon MC, Khan MA, Nuttall FQ. Glucose appearance rate after the ingestion of galactose. Metabolism. 2001 Jan;50(1):93-8. doi: 10.1053/meta.2001.19442.
Results Reference
result
PubMed Identifier
11238483
Citation
Gannon MC, Nuttall JA, Damberg G, Gupta V, Nuttall FQ. Effect of protein ingestion on the glucose appearance rate in people with type 2 diabetes. J Clin Endocrinol Metab. 2001 Mar;86(3):1040-7. doi: 10.1210/jcem.86.3.7263.
Results Reference
result
PubMed Identifier
12145777
Citation
Saeed A, Jones SA, Nuttall FQ, Gannon MC. A fasting-induced decrease in plasma glucose concentration does not affect the insulin response to ingested protein in people with type 2 diabetes. Metabolism. 2002 Aug;51(8):1027-33. doi: 10.1053/meta.2002.34033.
Results Reference
result
PubMed Identifier
12399273
Citation
Gannon MC, Nuttall JA, Nuttall FQ. Oral arginine does not stimulate an increase in insulin concentration but delays glucose disposal. Am J Clin Nutr. 2002 Nov;76(5):1016-22. doi: 10.1093/ajcn/76.5.1016.
Results Reference
result
PubMed Identifier
12450897
Citation
Gannon MC, Nuttall JA, Nuttall FQ. The metabolic response to ingested glycine. Am J Clin Nutr. 2002 Dec;76(6):1302-7. doi: 10.1093/ajcn/76.6.1302.
Results Reference
result
PubMed Identifier
12915639
Citation
Nuttall FQ, Gannon MC, Saeed A, Jordan K, Hoover H. The metabolic response of subjects with type 2 diabetes to a high-protein, weight-maintenance diet. J Clin Endocrinol Metab. 2003 Aug;88(8):3577-83. doi: 10.1210/jc.2003-030419.
Results Reference
result
PubMed Identifier
14522731
Citation
Gannon MC, Nuttall FQ, Saeed A, Jordan K, Hoover H. An increase in dietary protein improves the blood glucose response in persons with type 2 diabetes. Am J Clin Nutr. 2003 Oct;78(4):734-41. doi: 10.1093/ajcn/78.4.734.
Results Reference
result
PubMed Identifier
14767878
Citation
Nuttall FQ, Gannon MC, Jordan K. The metabolic response to ingestion of proline with and without glucose. Metabolism. 2004 Feb;53(2):241-6. doi: 10.1016/j.metabol.2003.09.013.
Results Reference
result
PubMed Identifier
15331548
Citation
Gannon MC, Nuttall FQ. Effect of a high-protein, low-carbohydrate diet on blood glucose control in people with type 2 diabetes. Diabetes. 2004 Sep;53(9):2375-82. doi: 10.2337/diabetes.53.9.2375.
Results Reference
result
PubMed Identifier
16423633
Citation
Nuttall FQ, Gannon MC. The metabolic response to a high-protein, low-carbohydrate diet in men with type 2 diabetes mellitus. Metabolism. 2006 Feb;55(2):243-51. doi: 10.1016/j.metabol.2005.08.027.
Results Reference
result
PubMed Identifier
16941278
Citation
Nuttall FQ, Schweim KJ, Gannon MC. Effect of orally administered phenylalanine with and without glucose on insulin, glucagon and glucose concentrations. Horm Metab Res. 2006 Aug;38(8):518-23. doi: 10.1055/s-2006-949523.
Results Reference
result
PubMed Identifier
19013300
Citation
Kalogeropoulou D, Lafave L, Schweim K, Gannon MC, Nuttall FQ. Leucine, when ingested with glucose, synergistically stimulates insulin secretion and lowers blood glucose. Metabolism. 2008 Dec;57(12):1747-52. doi: 10.1016/j.metabol.2008.09.001.
Results Reference
result
PubMed Identifier
19553295
Citation
Kalogeropoulou D, LaFave L, Schweim K, Gannon MC, Nuttall FQ. Lysine ingestion markedly attenuates the glucose response to ingested glucose without a change in insulin response. Am J Clin Nutr. 2009 Aug;90(2):314-20. doi: 10.3945/ajcn.2008.27381. Epub 2009 Jun 24.
Results Reference
result
PubMed Identifier
20150602
Citation
Radulescu A, Hassan Y, Gannon MC, Nuttall FQ. The degree of saturation of fatty acids in dietary fats does not affect the metabolic response to ingested carbohydrate. J Am Coll Nutr. 2009 Jun;28(3):286-95. doi: 10.1080/07315724.2009.10719783.
Results Reference
result
PubMed Identifier
20444922
Citation
Radulescu A, Gannon MC, Nuttall FQ. The effect on glucagon, glucagon-like peptide-1, total and acyl-ghrelin of dietary fats ingested with and without potato. J Clin Endocrinol Metab. 2010 Jul;95(7):3385-91. doi: 10.1210/jc.2009-2559. Epub 2010 May 5.
Results Reference
result
PubMed Identifier
20882645
Citation
Gannon MC, Nuttall FQ. Amino acid ingestion and glucose metabolism--a review. IUBMB Life. 2010 Sep;62(9):660-8. doi: 10.1002/iub.375.
Results Reference
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Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

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