Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance
Status:
Not yet recruiting
Trial end date:
2025-01-30
Target enrollment:
Participant gender:
Summary
Background:
Lipodystrophy (LD) syndromes are a group of rare disorders that affect how a person s body
can store and use fat tissue. Many people with LDs become severely insulin resistant. Some
people are insulin resistant because of a variant in the insulin receptor gene. Insulin
resistance causes many health problems.
Objective:
To learn if blocking the effects of growth hormone in the body will help people with severe
insulin resistance.
Eligibility:
Adults aged 18 to 65 years with either a known variant in the insulin receptor gene or with a
diagnosis of partial LD.
Design:
Participants will have 2 hospital stays, about 1 month apart. Each stay will be 3 or 4
nights.
During each hospital stay, participants will have many tests. They will have a physical exam
with blood tests. They will have all of their urine collected for a 24-hour period. They will
have scans to measure their muscle, bone, and fat tissues. They will have tests to measure
metabolism and insulin sensitivity. They may have an optional biopsy of fat tissue.
During the first hospital visit, participants will learn how to give themselves shots of a
drug (pegvisomant) that blocks growth hormone. The drug is injected under the skin.
Participants will continue to give themselves these shots once a day at home.
After the first hospital visit, participants will talk on the phone with members of the study
team once each week. After 2 weeks they will have blood drawn for tests.
Participants will stop the shots after the second hospital visit.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)