Status:
COMPLETED
Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
Lead Sponsor:
Baylor College of Medicine
Conditions:
HIV Lipodystrophy
Eligibility:
MALE
18-64 years
Phase:
NA
Brief Summary
"HIV lipodystrophy syndrome" (HLS) is characterized by loss of fat in the arms and legs, with increase in fat in the abdomen, and abnormal blood lipid levels. Persons with HLS have high risk for cardi...
Detailed Description
The HIV lipodystrophy syndrome (HLS) is characterized by peripheral fat wasting and central obesity, and hyperlipidemia (mainly hypertriglyceridemia), which results in insulin resistance. HLS patients...
Eligibility Criteria
Inclusion
- predominantly lipoatrophic or mixed phenotype of HIV-lipodystrophy (based on self-observation and evaluation by a study physician utilizing a visual scale;
- AM fasting leptin \< 4.0 ng/ml
- hypertriglyceridemia (fasting serum TG 250-1000 mg /dl).
- normal biochemistry (except altered lipid and glucose profile). Patients with the American Diabetes Association diagnostic criteria for diabetes were included provided the HbA1c level was \<7.5% and they received no anti-diabetic medications for at least 3 months.
- well-controlled HIV infection status evidenced by viral RNA titers \<400 copies/ml, on stable HAART.
Exclusion
- acute or chronic illnesses.
- use of antidiabetic medications in the previous 3 months, or of lipid-lowering drugs in the previous 6 weeks are also exclusion criteria. Other drugs excluded are growth hormone (if used without evidence of growth hormone deficiency), Megace and testosterone (if used without evidence of hypogonadism).
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01511016
Start Date
February 1 2003
End Date
October 1 2011
Last Update
January 27 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030