Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

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

Sponsors

Lead Sponsor: Minneapolis Veterans Affairs Medical Center

Source 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).

Overall Status Suspended
Start Date August 1982
Completion Date November 6, 2017
Primary Completion Date November 6, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in blood glucose concentration several time points after ingestion of test substance
Secondary Outcome
Measure Time Frame
Change in serum insulin concentration Several time points after ingestion of test substance
Enrollment 300
Condition
Intervention

Intervention Type: Other

Intervention Name: water, glucose with or without amino acid

Description: 240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass

Other Name: foods or food constituents

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Frank Q Nuttall, M.D., Ph.D. Principal Investigator Minneapolis Veterans Affairs Medical Center
Location
Facility: Minneapolis VA Health Care System
Location Countries

United States

Verification Date

November 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Minneapolis Veterans Affairs Medical Center

Investigator Full Name: Frank Q. Nuttall, MD, PhD

Investigator Title: Section of Endocrinology, Metabolism & Nutrition, Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Control

Type: Placebo Comparator

Description: 240 ml water

Label: glucose

Type: Active Comparator

Description: 50 g glucose

Label: Amino acid

Type: Active Comparator

Description: 1 mmol amino acid/kg lean body mass

Label: amino acid plus glucose

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: Single (Participant)

Source: ClinicalTrials.gov