Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)

June 30, 2014 updated by: US Department of Veterans Affairs

2895 Effect of a High Protein Diet on the 24-hr Profile of Ghrelin, GH and IGF-1

In this study we tested the hypothesis that an increase in protein content of the diet will result in an increase in the 24-hour integrated circulating growth hormone (GH) and insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in people with untreated type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects with untreated type 2 diabetes were studied using a randomized crossover design. The study began with an initial two-week observation period. Subjects then were randomly assigned to one arm of the study for 5 weeks. The carbohydrate:protein:fat ratio for the control diet is 55:15:30 whereas for the test diet it is 40:30:30. Following a five-week washout period, subjects were assigned to the other arm of the study. All meals were provided by the SDTU. A six-day rotating meal plan has been devised. At the beginning and end of the 5-week diet period, the subject was admitted to the SDTU (Special Diagnostic and Treatment Unit), was provided with the meals appropriate for the test or control arm of the study, and had blood drawn at various times during a 24-hour period. In addition to measurement of GH and IGF-1, IGF-binding proteins 1 and 3, ghrelin, and body composition were determined.

Study Type

Interventional

Enrollment (Actual)

8

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
        • VA Medical Center, Minneapolis

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

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People ages 55 - 75 years old with type 2 diabetes, not receiving oral hypoglycemic agents or insulin.
  • Fasting plasma glucose < 250 mg/dl (<14 mM) (tGHb < 14%).

Exclusion Criteria:

  • Subjects will be screened for hematological abnormalities, liver disease, kidney disease, macroalbuminuria (>300 mg/24 hours), untreated thyroid disease, congestive heart failure, angina, life-threatening malignancies, proliferative retinopathy, diabetic neuropathy, peripheral vascular disease, serious psychological disorders, a body mass index > 35, and a fasting triglyceride of > 400 mg/dl.
  • Presence of any of the above will be considered exclusion criteria.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
30% carbohydrate, 30% protein, 40% fat
Other: LoBag Diet - test phase
A Low Biologically Available Glucose (LOBAG30), weight maintaining diet consisting of 30% carbohydrate, 30% protein, 40% fat will be provided to subjects for 5 weeks.
Placebo Comparator: Arm 2
55% carbohydrate, 15% protein, 30% fat
Other: LoBAG Diet - control phase
A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IGF-1, GH, Body Composition
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

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

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Mary Gannon, PhD, 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

July 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria

April 14, 2005

First Posted (Estimate)

April 15, 2005

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03448-A

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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