Weight Loss With Exenatide Treatment - Full Text View

Purpose

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.

Condition	Intervention
Obesity	Drug: Exenatide Drug: Placebo Behavioral: Dietary counseling

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Mechanisms and Patterns of Weight Loss with Exenatide Treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 Outcome Measures:

Metabolic Characteristics that Predict Robust Response to Exenatide Treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The secondary objective of this study is:

- To identify metabolic characteristics that predict robust response to exenatide treatment

Estimated Enrollment:	200
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Exenatide Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 25 percent (1 in 4) chance of being assigned to the placebo study treatment group and a 75 percent (3 in 4) chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling. Subjects may or may not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the study team will know which they are receiving.	Drug: Exenatide Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study. Behavioral: Dietary counseling All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.
Placebo Comparator: Placebo Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 25 percent (1 in 4) chance of being assigned to the placebo study treatment group and a 75 percent (3 in 4) chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling. Subjects may or may not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the study team will know which they are receiving.	Drug: Placebo Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study. Behavioral: Dietary counseling All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.

Arms

Assigned Interventions

Experimental: Exenatide

Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 25 percent (1 in 4) chance of being assigned to the placebo study treatment group and a 75 percent (3 in 4) chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling. Subjects may or may not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the study team will know which they are receiving.

Drug: Exenatide

Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.

Behavioral: Dietary counseling

All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.

Placebo Comparator: Placebo

Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 25 percent (1 in 4) chance of being assigned to the placebo study treatment group and a 75 percent (3 in 4) chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling. Subjects may or may not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the study team will know which they are receiving.

Drug: Placebo

Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.

Behavioral: Dietary counseling

All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.

Detailed Description:

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590433

Contacts

Contact: Tahereh Ghorbani, MD	617-667-1996	bodyweightstudy@bidmc.harvard.edu
Contact: Jody Dushay, MD	617-667-1996	bodyweightstudy@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jody Dushay, MD 617-667-1996
Sub-Investigator: Jody Dushay, MD
Sub-Investigator: Tahereh Ghorbani, MD
Sub-Investigator: Emilie Mitten, BA
Principal Investigator: Eleftheria Maratos-Flier, MD

Sponsors and Collaborators

Eleftheria Maratos-Flier

Amylin Pharmaceuticals, LLC.

Investigators

Principal Investigator:

Eleftheria Maratos-Flier, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Eleftheria Maratos-Flier, Principal Investigator, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01590433 History of Changes
Other Study ID Numbers:	2011P-000310
Study First Received:	February 24, 2012
Last Updated:	May 2, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Obesity
Overweight
Exenatide
Diet
Women

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight

Signs and Symptoms
Body Weight Changes
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013