Efectos de la Liposucción de Gran Volumen sobre las Complicaciones Metabólicas en Pacientes con Sobrepeso con Hiperinsulinemia o Diabetes Tipo 2

Fecha de inicio: 1 de mayo de 2000

Patients must be in good general health. Patients with chronic stable complications of Type 2 diabetes or stable obesity related comorbid conditions will not be excluded. Obesity: Defined as subjects having a body mass index greater than 30 kg/m(2). Weight must be less than 300 lb (136 kg) because of limits related to the DXA and CT scanners. Patients with Type 2 Diabetes, impaired glucose tolerance, or hyperinsulinemia are eligible. Patients' age must be greater than or equal to 18 years at the start of the study. Patients must be planning to undergo large volume liposuction. Premenopausal women participating in the study must have a negative pregnancy test at the start of the study and will be required to remain on some form of effective contraception for the duration of the study. Patients recruited for the pilot study will be required to have all four grandparents and both parents to be either all non-Hispanic Caucasians or non-Hispanic African-American. Volunteers with the presence of significant, unstable or evolving renal disease are not eligible. Subjects must not have calculated (age and weight corrected) creatinine clearances below 50 ml/min or significant worsening of serum creatinine levels during the course of the study (greater than 30% increase from baseline). Volunteers with the presence of significant, unstable or evolving hepatic disease associated with SGOT and/or SGPT greater than 2.5 times normal are not eligible. Volunteers with the presence of significant, evolving or unstable cardiac disease are not eligible. Subjects with NYHA stage 3 or 4 disease will be excluded from the study. Volunteers with the presence of significant, evolving or unstable pulmonary disease including uncontrolled bronchial asthma and/or chronic bronchitis are not eligible. Volunteers with the presence of other uncontrolled or unstable medical conditions including uncontrolled thyroid disease, Cushing's syndrome, autoimmune or gastrointestinal disease are not eligible. Volunteers who are pregnant are not eligible. Volunteers must not have uncontrolled Type 2 diabetes as evidenced by recent coma or pre-coma states, frequent episodes of hypoglycemia, predominantly severe hyperglycemia (plasma glucose greater than 400 mg/dl) in the past three months prior to study commencement, a glycosylated hemoglobin (HBA1C) value greater than 10 in the past three months prior to the study commencement, and frequent or recurrent episodes of ketosis (ketonuria and/or ketonemia). Volunteers with uncontrolled, significant or evolving psychiatric/psychological syndromes which in the opinion of the investigators would place the patient at increased risk during the course of the study or would impede competence and/or ability to complete the study are not eligible. Volunteers with current history of illicit substance abuse and/or alcoholism based on reported history and the CAGE questionnaire are not eligible. Volunteers must not have a recent use (within the preceding 6 months) of anorexiant medications or medications that would affect nutrient absorption such as orlistat or acarbose. Volunteers must not be receiving treatment with an insulin-sensitizing medication such as metformin or the thiazolidinediones. Use of insulin, meglitides or the sulphonylureas will not constitute an exclusion. Volunteers with an absence of spontaneous menses for greater than 1 year are not eligible.