Leptin to Treat Lipodystrophy
Lipodystrophy
About this trial
This is an interventional treatment trial for Lipodystrophy focused on measuring Adipocyte - Development, Insulin Resistance, Dyslipidemia, Diabetes Mellitus, Non-Alcoholic Steatohepatitis, Leptin Replacement
Eligibility Criteria
INCLUSION CRITERIA: All ethnic groups Males and females Age greater than 14 years Clinically-significant lipodystrophy, identified by the study physician during the physical examination as an absence of fat outside the range of normal variation and/or identified as a disfiguring factor by the patient. Circulating leptin levels less than 4.0 ng/ml in females and less than 3.0 ng/ml in males as measured by Linco assay on at least 2 occasions. Presence of at least one of the following metabolic abnormalities: Presence of diabetes as defined by the 1997 ADA criteria: a) fasting plasma glucose greater than or equal to 126 mg/dL, or b) 2 hour plasma glucose greater than or equal to 200 mg/dL following a 75 gram oral glucose load, or c) diabetic symptoms with a random plasma glucose greater than or equal to 200 mg/dL. Fasting insulin greater than 30 micrograms/ml; Fasting hypertriglyceridemia greater than 200 mg/dl. EXCLUSION General: Pregnant women, women in their reproductive years who do not use an effective method of birth control, women currently nursing or lactating within 6 weeks of having completed nursing, and persons who are unable to provide informed consent will be excluded from the study. Exclusions for underlying disease likely to increase side effects or to hinder objective data collection: Known liver disease due to causes other than non-alcoholic steatohepatitis Current alcohol or substance abuse Psychiatric disorder impeding competence or compliance Active tuberculosis Use of anorexiogenic drugs Other condition which in the opinion of the clinical investigators would impede completion of the study Subjects who have a known hypersensitivity to E. Coli derived proteins
Sites / Locations
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)