Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
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|ClinicalTrials.gov Identifier: NCT00896298|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : December 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypoleptinemia Generalized Lipodystrophy Partial Lipodystrophy Insulin Resistance||Drug: Leptin Drug: Placebo||Phase 2 Phase 3|
The mechanism by which leptin improves glucose and lipid control is not clear. We will examine the possible mechanisms of leptin action by studying the effects of leptin administration on food intake, insulin resistance, insulin secretory response, hepatic and intramuscular triglyceride stores in a large sample of patients with lipodystrophy.
Hypothesis: Leptin replacement in patients with generalized and partial lipodystrophy and hypoleptinemia will be safe and efficacious in improving the metabolic abnormalities associated with insulin resistance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With Lipodystrophy|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: 1 Leptin
Active Comparator for 4 months, then for 8 months.
Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.
Placebo Comparator: 2 Sugar pill
Placebo for 4 months, then active comparator for 8 months.
- Project Specific: to determine if r-metHuLeptin can be safely replaced in hypoleptinemic patients with generalized and partial lipodystrophies. [ Time Frame: 12 months ]
- Project Specific: to determine if r-metHuLeptin administration is effective in improving glucose and lipid abnormalities in hypoleptinemic patients with generalized and partial lipodystrophies. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896298
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Abhimanyu Garg, MD||UT Southwestern Medical Center|