Skip to main content
OpenTrials
Completed

NCT Number: NCT00108225

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LoBag Diet - test phase

Other

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.

LoBAG Diet - control phase

Other

A control, weight maintaining diet consisting of 55% carbohydrate, 15% protein, 30% fat will be provided to subjects for 5 weeks

Primary outcomes

  1. IGF-1, GH, Body Composition

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Apr 15, 2005
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.