Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01471509
• Other study ID #: 676
• Status: Suspended
• Phase: N/A
• First received: November 10, 2011
• Last updated: November 6, 2017
• Start date: August 1982
• Est. completion date: November 6, 2017

Study information

• Verified date: November 2017
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Type 2 Diabetes

Intervention

Other:
• water, glucose with or without amino acid
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (43)

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. — View 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. — View 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. — View 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. — View Citation

Gannon MC, Khan MA, Nuttall FQ. Glucose appearance rate after the ingestion of galactose. Metabolism. 2001 Jan;50(1):93-8. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Gannon MC, Nuttall FQ. Factors affecting interpretation of postprandial glucose and insulin areas. Diabetes Care. 1987 Nov-Dec;10(6):759-63. — View Citation

Gannon MC, Nuttall FQ. Quantitation of the glucose area response to a meal. Diabetes Care. 1990 Oct;13(10):1095-6. — View 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. — View 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. — View Citation

Gannon MC, Nuttall JA, Nuttall FQ. The metabolic response to ingested glycine. Am J Clin Nutr. 2002 Dec;76(6):1302-7. — View 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. — View 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. — View 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. — View 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. — View 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 200 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Nuttall FQ, Gannon MC. Metabolic response to egg white and cottage cheese protein in normal subjects. Metabolism. 1990 Jul;39(7):749-55. — View 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. Review. — View 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. — View 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. — View Citation

Nuttall FQ, Khan MA, Gannon MC. Peripheral glucose appearance rate following fructose ingestion in normal subjects. Metabolism. 2000 Dec;49(12):1565-71. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	several time points after ingestion of test substance
Secondary	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.	Several time points after ingestion of test substance