Weight Loss With Exenatide Treatment

Obesity Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity
• Weight Loss

• NCT number: NCT01590433
• Study type: Interventional
• Source: Beth Israel Deaconess Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: March 2012
• Completion date: January 2019