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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00108225

Run by

US Department of Veterans Affairs

People needed

8

Starts

2004-07-01

Expected to finish

2009-05-01

Last updated by the study team

2014-07-01

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%).

You may not qualify if…

• 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.

Where it is running

• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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