Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

November 6, 2017 updated by: Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
240 ml water
Other: water, glucose with or without amino acid
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Other Names:
  • foods or food constituents
Active Comparator: glucose
50 g glucose
Other: water, glucose with or without amino acid
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Other Names:
  • foods or food constituents
Active Comparator: Amino acid
1 mmol amino acid/kg lean body mass
Other: water, glucose with or without amino acid
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Other Names:
  • foods or food constituents
Active Comparator: amino acid plus glucose
50 g glucose plus 1 mmol amino acid/kg lean body mass
Other: water, glucose with or without amino acid
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Other Names:
  • foods or food constituents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose concentration
Time Frame: 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.
several time points after ingestion of test substance

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum insulin concentration
Time Frame: 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.
Several time points after ingestion of test substance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Frank Q Nuttall, M.D., Ph.D., Minneapolis Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1982

Primary Completion (Actual)

November 6, 2017

Study Completion (Anticipated)

November 6, 2017

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 676

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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