Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

Insulin Resistance Clinical Trial

Official title:

Double-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896298
• Other study ID #: 0502-294
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Generalized Lipodystrophy
• Hypoleptinemia
• Insulin Resistance
• Lipodystrophy
• Partial Lipodystrophy

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