Health Effects of Liposuction in Overweight Women With Elevated Insulin Levels, Impaired Glucose Tolerance and/or Type 2 Diabetes
|First Received Date ICMJE||May 26, 2000|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||May 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005760 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Health Effects of Liposuction in Overweight Women With Elevated Insulin Levels, Impaired Glucose Tolerance and/or Type 2 Diabetes|
|Official Title ICMJE||A Pilot Study of the Metabolic Effects of Large Volume Liposuction in Overweight Women With Hyperinsulinemia, Impaired Glucose Tolerance and/or Type 2 Diabetes|
This study is for women who have already decided to undergo liposuction at Georgetown University Medical Center in Washington, D.C. To take part in this study, a woman must first meet with the plastic surgeons there, and be accepted by them to have liposuction. This study will investigate whether large volume liposuction improves risk factors for heart disease in overweight women with type 2 (adult onset) diabetes, impaired glucose tolerance, or elevated blood insulin levels. Large volume liposuction is the surgical removal of at least 10 pounds (4.5 kg) of body fat, usually from the abdomen, hips or chest. Risk factors for heart disease include high blood pressure and elevated levels of blood lipids (cholesterol and triglycerides), blood glucose (sugar), and blood insulin. Subjects who participate in all parts of this study will receive a total of $930.00.
Overweight women 18 years or older with high blood insulin levels, impaired glucose tolerance, or type 2 diabetes, who are planning to have large volume liposuction performed at Georgetown University Medical Center in Washington, D.C., may be eligible for this study. For a subject to be accepted into this study, she must first meet with the plastic surgeons at Georgetown University Medical Center, and they have to agree to perform large volume liposuction. The decision that someone is suitable for liposuction is not under the control of the NIH or of any NIH investigator.
Those enrolled will undergo the following procedures at four separate times - before undergoing liposuction, 4 weeks after surgery, 4 months after surgery and 1 year after surgery:
Obesity is a major predisposing factor for future Type 2 diabetes because it is often associated with insulin resistance and impaired glucose tolerance. Insulin resistance has been suggested as the common link for other aspects of the cardiac dysmetabolic syndrome that includes hypertension, dyslipidemia, obesity, and macrovascular arterial disease. There are racial disparities in the prevalence of both obesity and Type 2 diabetes: Compared with non-Hispanic Caucasians, African American women have almost twice the prevalence of overweight, obesity, and Type 2 diabetes.
Because data from predominantly Caucasian populations suggest that the quantity of truncal (sometimes called upper body) adipose tissue, which includes the adipose tissue surrounding the abdominal viscera, is far more important for risk stratification than that found in the limbs or buttocks, which contain subcutaneous adipose tissue, it has been presumed that attempts at treatment of obesity should concentrate on reducing visceral fat. However, despite their greater risks for the complications of obesity, African Americans have less visceral abdominal adipose tissue than Caucasians matched for body weight. Further, recent metabolic studies suggest that upper body subcutaneous adipose tissue may play a significant role, particularly for African Americans, in the comorbid metabolic conditions associated with obesity.
With the advent of the large volume liposuction technique, selective removal of substantial quantities of subcutaneous adipose tissue has become possible. It is unknown whether the complications of obesity can be ameliorated by removal of subcutaneous adipose tissue, but one preliminary study suggests that fasting hyperinsulinism can be improved by this approach.
We propose to conduct a pilot study of 10 patients (five Caucasians and five African-Americans) who plan to undergo liposuction. We will investigate how large volume liposuction affects the metabolic complications of obesity in overweight patients who have hyperinsulinemia, impaired glucose tolerance, or type 2 diabetes. We will investigate the effects of liposuction on various indices of the cardiac dysmetabolic syndrome by performing studies of insulin sensitivity and lipid metabolism at four time points: before large volume liposuction, 1 month after liposuction, 4 months after liposuction, and 1 year after liposuction. At each visit we will study body composition, blood pressure, cardiac function, dietary habits, insulin insensitivity, free fatty acids, and lipid profiles.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00005760|
|Other Study ID Numbers ICMJE||000115, 00-CH-0115|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP