weight loss with exenatide treatment

Conditions: Obesity

Summary: the investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. the investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment. hypothesis: the mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters. by identifying and following a group of obese women who lose greater than 5% body weight after short-term exenatide treatment, the investigators can gain insights into the possible mechanisms of weight loss and assess long-term weight loss with this pharmacotherapeutic intervention.

primary outcomes the primary objectives of this study is: - to investigate possible mechanisms and patterns of weight loss with exenatide treatment, especially among individuals who have robust early weight loss (greater than 5% weight loss in 12 weeks) with exenatide. secondary outcomes our secondary objective is to identify metabolic characteristics that predict robust response to exenatide treatment. outcome measurements: * weight * body composition * resting energy expenditure (ree) * mixed meal test * thermic effect of food * serum metabolic parameters * hunger/nausea/satiety visual analog scales (vas) * physical activity monitoring study population the study population will be generally healthy, non-diabetic women age 18-70 years with bmi 28-48 kg/m\^2.

Eligibility criteria:
inclusion criteria: * females age 18-70 * bmi 28-48 kg/m\^2 * stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit). * ability to give informed consent and follow verbal and written instructions in english. exclusion criteria: * type 1 or type 2 diabetes mellitus diagnosed according to american diabetes association criteria * unstable heart disease as evidenced by ongoing angina * congestive heart failure * uncontrolled hypertension (bp greater than 170/100 mmhg on or off antihypertensive medication) * uncontrolled dyslipidemia (ldl greater than 200 or tg greater than 400 on or off lipid lowering medication) * tobacco, marijuana, cocaine, or intravenous drug use * shift workers (night shift or alternating day/night shifts) * gastroparesis * inflammatory bowel disease or irritable bowel syndrome * malignancy treated with chemotherapy within the past 3 years * history of pancreatitis * depression requiring hospitalization or diagnosis of psychosis * renal insufficiency (egfr less than 50) * transaminases greater than 2 times above the normal range * pregnancy within 6 months of the screening visit * lactation * failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) * history of an eating disorder (anorexia, bulimia or laxative abuse) * treatment with fda-approved or over-the-counter weight loss medication within 6 months, with the exception of xenical if there was no weight loss * history of gastric bypass surgery or gastric stapling * biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit * previous treatment with exenatide * discretion of the pi

Keywords: obesity overweight exenatide diet women