Status:
COMPLETED
Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Hypoleptinemia
Generalized Lipodystrophy
Eligibility:
All Genders
6-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of t...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- age \> 6 years
- Partial and generalized lipodystrophy
- Serum leptin levels less than the 7th percentile of normal values reported by the 3rd National Health and Nutrition Examination survey (less than 7.0 ng/mL in females and less than 3/0 ng/mL in males)
- Presence of at least one of the following metabolic abnormalities:
- Type 2 Diabetes Mellitus
- Fasting serum insulin \>20 uU/mL
- Fasting serum triglycerides \> 300 mg/dL
- Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study.
Exclusion
- Known liver disease due to causes other than non-alcoholic steatohepatitis.
- Hematocrit of less than 30%.
- Current alcohol or substance abuse.
- Use of anorexigenic drugs, anabolic steroids, GH and thiazolidinediones
- Active tuberculosis
- Psychiatric disorder impeding competence or compliance
- Malignancies
- HIV infection
- Subjects who have a known hypersensitivity to E. Coli derived proteins
- Other condition, which in the opinion of the clinical investigators would impede completion of the study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00896298
Start Date
April 1 2006
End Date
November 1 2014
Last Update
March 27 2024
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390