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MinorStart date changed from estimate of Jan 30, 2023 to Jan 23, 2023v129
MinorStart date: Jan 29, 2023 to Jan 30, 2023v128
MinorStart date: Jan 26, 2023 to Jan 29, 2023v127
MinorStart date: Jan 25, 2023 to Jan 26, 2023v126
MinorStart date: Jan 24, 2023 to Jan 25, 2023v125
MinorStart date: Jan 23, 2023 to Jan 24, 2023v124
MinorStart date: Jan 19, 2023 to Jan 23, 2023v123
MinorStart date: Jan 18, 2023 to Jan 19, 2023v122
MinorStart date: Jan 17, 2023 to Jan 18, 2023v121
MinorStart date: Jan 16, 2023 to Jan 17, 2023v120
MinorStart date: Jan 15, 2023 to Jan 16, 2023v119
MinorStart date: Jan 12, 2023 to Jan 15, 2023v118
MinorStart date: Jan 11, 2023 to Jan 12, 2023v117
MinorStart date: Jan 10, 2023 to Jan 11, 2023v116
MinorStart date: Jan 9, 2023 to Jan 10, 2023v115
MinorStart date: Jan 5, 2023 to Jan 9, 2023v114
MinorStart date: Jan 4, 2023 to Jan 5, 2023v113
MinorStart date: Jan 3, 2023 to Jan 4, 2023v112
MinorStart date: Jan 2, 2023 to Jan 3, 2023v111
MinorStart date: Dec 29, 2022 to Jan 2, 2023v110
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.