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Protein, Amino Acids & Insulin & Glucagon Secretion in Humans

This study is currently recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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
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
Diabetes Mellitus, Type 2
Endocrine System Diseases
Hyperinsulinism
Glucagon
 Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 19, 2013