A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02215 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01590433 |
| Primary Contact: |
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Principal Investigator
Eleftheria Maratos-Flier, MD
Beth Israel Deaconess Medical Center
Tahereh Ghorbani, MD
Phone: 617-667-1996
Email: bodyweightstudy@bidmc.harvard.edu
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| Backup Contact: |
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Email: bodyweightstudy@bidmc.harvard.edu
Jody Dushay, MD
Phone: 617-667-1996
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| Location Contact: |
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Boston, Massachusetts 02215
United States
Jody Dushay, MD
Phone: 617-667-1996
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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