Weight Loss With Exenatide Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01590433
First received: February 24, 2012
Last updated: May 2, 2012
Last verified: May 2012
  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:


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014