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

NCT ID: NCT02023918

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Diabetes; Metabolic Syndrome; Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegvisomant arm

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

Group Type: EXPERIMENTAL

pegvisomant

Intervention Type: DRUG

Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Interventions

pegvisomant

Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Intervention Type: DRUG

Other Intervention Names

Somavert

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco General Hospital

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ethan J Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Morris Schambelan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kathleen Mulligan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

WI178028

Identifier Type: -

Identifier Source: org_study_id