9 Clinical Trials for Various Conditions
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.
LIPO-102 is under evaluation for treatment of abdominal adiposity
Dose-ranging, randomized, double-blind, vehicle-controlled study
Twelve obese patients approved for gastric bypass surgery will be randomized to either receive an MCT-based or LCT-based liquid diet for a 4 week period. These diets will be identical except for the quality of the fat. The intervention will be double-blinded. Six patients will receive a daily diet consisting of 5 liquid meals using the HMR 800 meal replacement product (Health Management Resources, Inc; 160 calories/shake) with 44.5 grams MCT oil (Life Enhancement Products, Inc., Petaluna, CA; 8.3 kcal/gm) added. Six patients will receive the same HMR diet but with 41 grams LCT oil (corn oil; 9 kcal/gm) added. Patients in both groups will be given a list of supplemental foods that are suitable for the study. They may choose to eat up to an additional 700 kcal per day from this list and will be asked to complete food records for monitoring of their caloric intake. Patients will undergo gastric bypass surgery after 4 weeks of being on their diets. Patients in both groups will be seen weekly by a registered dietitian and a physician. Blood pressure and weight will be recorded, and any adverse events will be noted and cared for as is appropriate. Dietary instruction will be reviewed as needed.Both diets will be 1170-1870 kcal/day, consisting of 36% CHO, 26.2% protein, and 37.6% fat. The MCT diet will contain 30.2% of total calories at MCT oil. The percentages given are based on the shake and oil consumption only (1170 kcal/day). The remainder of the diet will vary according to patients' selections from the list of permitted foods, up to an additional 700 kcal/day (for the total 1870 kcal/day). All subjects will receive a multi-vitamin each day. Subjects will also receive two Fibercon capsules per day to prevent possible bowel changes associated with being on a full liquid diet. During surgery, biopsies of visceral and omental adipose tissue, as well as subcutaneous abdominal adipose tissue, will be obtained. Tissue will be analyzed to determine mRNA levels of key enzymes in fatty acid esterification, lipolysis, and oxidative disposition. This preliminary phase will be conducted to determine whether visceral, omental, and subcutaneous abdominal adipose tissue behave similarly when exposed to an MCT-based diet.
Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.
Lipedema is characterized by an abnormal deposition of adipose tissue, resulting in fluid accumulation, limb enlargement, and pain. Lipedema is often misdiagnosed as simply obesity. A major challenge with diagnosis is the poorly understood biology underlying the disease. Limited studies suggest that the development of lipedema may involve adipocyte hypertrophy, increased commitment of adipose progenitor cells, hypoxia, adipocyte necrosis and macrophage recruitment. There remains an urgent need to investigate novel characteristics of adipose remodeling that may contribute to the pathogenesis of lipedema. The study investigators have reported quantitative measures of in vivo adipose kinetics using an 8-week incorporation of deuterium (administered as 2H2O) into the adipose tissue of women with obesity. The objective of this proposal is to utilize the metabolic 2H-labeling approach to measure, for the first time, in vivo adipocyte formation and triglyceride synthesis in the adipose tissue of participants with lipedema. Imaging approaches will provide a range of measurements to characterize the lipedema depots. The investigators hypothesize that lipedema adipose depots will have higher rates of adipocyte formation and triglyceride synthesis than both non-lipedema depots and those of women with traditional obesity. Lipedema may involve adipose tissue remodeling, characterized by adipocyte hypertrophy and increased commitment of preadipocytes and differentiation of adipocytes (adipogenesis), yielding an abundance of adipocytes with limited capacity to expand and accommodate lipid, resulting in hypoxia, macrophage recruitment, and local/systemic inflammation. Findings from this proposal will contribute to a better understanding of the pathogenesis of lipedema and may provide insight for the future development of therapeutic targets.
Study the effects of different exercise modes on total and regional adiposity variation in subcutaneous and visceral adipose tissue (VAT and SAT). The investigators hypothesize that total abdominal will improve for all the exercise groups compared to the control group. When comparing intervention groups: 1) no differences on the degree of improvement in total abdominal fat depots (VAT and SAT) 2) different degree of change when comparing specific sections at VAT and SAT are expected.
The goal of this project is to compare visceral fat measurements derived from Lunar iDXA total body scans and from Computed Tomography (CT) scans of the abdominal region.
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: * Body measurements - taken with calipers to measure several skinfold thicknesses (the width of a fat fold) and with a tape measure to measure the circumference of parts of the body. * Urine sample and 6-hour urine collection - to test for pregnancy and to evaluate kidney function. * Glucose tolerance test - measures insulin sensitivity and how the body uses sugar, how well insulin works, and insulin sensitivity. The procedure involves placement of two catheters (thin, flexible tubes) through a needle into a vein in each arm. Sugar water is infused into one catheter and 20 minutes into the test a small amount of insulin is injected. Blood samples are drawn from the other catheter at frequent intervals for a total of 5 hours. * Electrocardiogram (ECG) and echocardiography - measure the heart's electrical activity and function. * Abdominal computerized tomography (CT) scan - produces images for measuring body fat in the abdomen. (not done at the 4-week visit). Takes about half an hour to complete. * DXA X-ray - measures body fat, muscle and bone mineral content. Takes about half an hour to complete. * Bod Pod - capsule-like device used to determine the proportion of body weight composed of fat and non-fat tissue. Takes less than 10 minutes * Bioelectric impedance analysis device - measures the proportions of body fat based on electrical conduction of a small electric current. Takes 2-3 minutes. * 24-hour blood pressure monitoring - a device attached to a blood pressure cuff strapped to the arm measures blood pressure every 15 to 30 minutes continuously for 24 hours. * Vascular reactivity tests - a blood pressure cuff is inflated for about 4 minutes before deflating, providing information on the function of the small blood vessels in the skin, as well as an idea of the function level of small blood vessels elsewhere in the body. Takes half an hour. * Blood samples - collected to evaluate kidney and liver function and to measure body lipids, such as cholesterol, minerals, and other substances.