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

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: LoBag Diet - test phase

Other: LoBAG Diet - control phase

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00108225

03448-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

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.