Weight Loss With Exenatide Treatment



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:10/13/2018
Start Date:March 2012
End Date:June 2019

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A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes

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.

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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-1996
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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