Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

Not Applicable

Suspended

• Conditions: Metabolic Syndrome; Type 2 Diabetes
• Interventions: Other: water, glucose with or without amino acid

• Registration Number: NCT01471509
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

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).

Study Timeline

• Study Start: 1982-08
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-15
• Status Verified: 2017-11
• Primary Completion: 2017-11-06
• Study Completion: 2017-11-06
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
glucose	water, glucose with or without amino acid	50 g glucose
amino acid plus glucose	water, glucose with or without amino acid	50 g glucose plus 1 mmol amino acid/kg lean body mass
Control	water, glucose with or without amino acid	240 ml water
Amino acid	water, glucose with or without amino acid	1 mmol amino acid/kg lean body mass

Primary Outcome Measures

Name	Time	Method
Change in blood glucose concentration	several time points after ingestion of test substance	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

Name	Time	Method
Change in serum insulin concentration	Several time points after ingestion of test substance	Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.

Trial Locations

Locations (1)

Minneapolis VA Health Care System; 🇺🇸 Minneapolis, Minnesota, United States