Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes

Completed · Phase 2

Conditions studied: Diabetes, Metabolic Syndrome, Insulin Resistance

In brief

Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.

Key facts

Study ID

NCT02023918

Run by

University of California, San Francisco

People needed

6

Starts

2014-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI between 18-35
• Homeostatic model assessment - insulin resistance (HOMA-IR) >2.77
• Able to administer daily subcutaneous injections of pegvisomant

You may not qualify if…

• Pregnancy
• Breastfeeding in the last 6 months
• Liver function tests greater than 3x the upper limits of normal
• unstable diet over the last 3 months
• unstable weight over the last 6 months
• unstable lipid lowering regimen
• diabetes - type 1 or type 2
• History of major gastrointestinal surgery
• History of pancreatic, liver, biliary, or intestinal disease
• Fasting blood glucose >126
• Fasting triglycerides>500
• A1c>6.5

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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