Weight Loss With Exenatide Treatment
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/16/2019 |
| Start Date: | March 2012 |
| End Date: | July 2019 |
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.
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.
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
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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