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NCT01778556 · ClinicalTrials.gov registry record · Phase 2
Short-term Effects of Leptin in People With Lipodystrophy
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01778556 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 25 participants.
The verdict
NCT01778556, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Metreleptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-01-26 |
| Est. Completion | 2018-02-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01778556
The ClinicalTrials.gov registry entry for NCT01778556 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Metreleptin is the first listed.
NCT01778556 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01778556 about?
NCT01778556 is a clinical study titled "Short-term Effects of Leptin in People With Lipodystrophy". 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 c...
What is the current status of trial NCT01778556?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-01-26. Estimated completion is 2018-02-23.
What interventions are being tested in trial NCT01778556?
The interventions under investigation include: Metreleptin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01778556?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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