CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Metreleptinbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01778556
NCT01778556Phase 2Completed

Short Term Effects of Leptin Withdrawal or Initiation in Lipodystrophy Independent of Energy Intake

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jan 29, 2013·Updated Nov 13, 2019

In Brief

A Phase 2 clinical trial evaluating Metreleptin for Lipodystrophy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Background: \- Lipodystrophy is a condition where people do not have enough fat in the body. People with lipodystrophy can have problems such as diabetes or an enlarged liver. Researchers are looking at how leptin, a hormone produced by fat cells, can help people with these problems. Leptin helps control appetite and how the body stores food. Taking leptin can help people with lipodystrophy eat less food, which may help treat diabetes and other problems. To better understand how leptin works, researchers want to do an inpatient study on leptin treatment in people with lipodystrophy. Objectives: \- To study how leptin treatment affects lipodystrophy. Eligibility: \- Individuals between 14 and 70 years of age who have lipodystrophy. Design: * All participants will have a 19-day stay at the National Institutes of Health Clinical Center. One group of participants will have tests for 5 days before starting to take leptin. They will then take leptin for 2 weeks, and have more tests. The other group of participants will have tests for 5 days while taking leptin. They will then take stop taking leptin for 2 weeks, and have more tests, and then they will start taking leptin again. * Participants will have regular blood and urine tests during the visit. Some of the blood tests will look at insulin levels. Some will look at how the body metabolizes sugar and fat. Other tests will check hormone levels, especially of reproductive hormones. * During the visit, participants will spend 3 separate days in a metabolic chamber, a special room that measures how many calories the body uses. Urine samples will be collected during these stays. * Participants will also have several body imaging studies, including magnetic resonance imaging and a body composition scan. * Physical activity will be tested with an exercise bicycle and an electronic activity monitor. * Participants will be asked questions about hunger and comfort levels throughout the stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipodystrophy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2013
Enrollment StartJan 26, 2013
Primary CompletionFeb 23, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 13.4 years ago

Interventions

Metreleptinbiological

Recombinant analog of the human hormone, leptin