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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Diabetes; Insulin Resistance; Metabolic Syndrome

Treatments: Drug: pegvisomant

Study type: Interventional

Funder types: Other

Identifiers

NCT02023918

WI178028

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Pegvisomant arm

Experimental group

Description:

Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.

Treatment:

Drug: pegvisomant