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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00896298
Other study ID # 0502-294
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 2006
Est. completion date November 2014

Study information

Verified date March 2024
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.


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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 6 Years to 70 Years
Eligibility Inclusion Criteria: - 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: 1. Type 2 Diabetes Mellitus 2. Fasting serum insulin >20 uU/mL 3. Fasting serum triglycerides > 300 mg/dL 4. Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study. Exclusion Criteria: - 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.

Study Design


Intervention

Drug:
Leptin
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
Sugar pill

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting Serum Triglycerides 4 months
Primary HbA1c 4 months
Secondary Fasting Serum Glucose 4 months
Secondary Body Weight 4 months
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