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NCT00025883 · ClinicalTrials.gov registry record · Phase 2
Leptin to Treat Lipodystrophy
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT00025883 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 103 participants.
The verdict
NCT00025883, 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
- 103 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and liver disease due to fat accumulation. Patients age greater than or equal to 6 months with significant lipodystrophy may be eligible for this study. Participants will be admitted to the NIH Clinical Center for 10 days for the following studies before beginning 12 months of leptin therapy: * Insulin tolerance test * Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. * Fasting blood tests * Resting metabolic rate * Magnetic resonance imaging of the liver and other organs, and of muscle and fat. * Pelvic ultrasound in women to detect ovarian cysts. * Estimation of body fat * Oral glucose tolerance test * Intravenous glucose tolerance test * Appetite level and food intake * Hormone function tests * Questionnaires to assess activity and mood * 24-hour urine collections Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle biopsy to study muscle proteins involved in regulating energy expenditure before and after leptin replacement, and examination of a surgical specimen (if available) to study molecules that may be involved in energy storage and use. When the above tests are completed, leptin therapy begins. The drug is injected under the skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the 1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts include a physical examination, blood tests and a meeting with a dietitian. At the end of 12 months, all baseline studies described above
Interventions
- DRUG Metreleptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2001-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00025883
The ClinicalTrials.gov registry entry for NCT00025883 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 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.
NCT00025883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00025883 about?
NCT00025883 is a clinical study titled "Leptin to Treat Lipodystrophy". This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes hi...
What is the current status of trial NCT00025883?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2001-10. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00025883?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT00025883?
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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