Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Minneapolis Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01471509
First received: November 10, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Metabolic Syndrome
Other: water, glucose with or without amino acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in blood glucose concentration [ Time Frame: several time points after ingestion of test substance ] [ Designated as safety issue: No ]
    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 [ Time Frame: Several time points after ingestion of test substance ] [ Designated as safety issue: No ]
    Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.


Estimated Enrollment: 300
Study Start Date: August 1982
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: foods or food constituents

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471509

Contacts
Contact: Frank Q Nuttall, M.D., Ph.D. 612-467-4424 nutta001@umn.edu
Contact: Mary C Gannon, Ph.D. 612-467-2895 ganno004@umn.edu

Locations
United States, Minnesota
Minneapolis VA Health Care System Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Frank Q Nuttall, M.D., Ph.D.    612-467-4424    nutta001@umn.edu   
Contact: Mary C. Gannon, Ph.D.    612/467-2895    ganno004@umn.edu   
Principal Investigator: Frank Q Nuttall, M.D, Ph.D.         
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Frank Q Nuttall, M.D., Ph.D. Minneapolis VA Health Care System
  More Information

Publications:

Responsible Party: Frank Q. Nuttall, MD, PhD, Chief, Section of Endocrinology, Metabolism & Nutrition, Professor of Medicine, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01471509     History of Changes
Other Study ID Numbers: 676
Study First Received: November 10, 2011
Last Updated: November 18, 2011
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Glycemic Index
LoBAG Diet
Insulin
Glucagon

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Insulin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Hyperinsulinism
Glucagon
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014