Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT01590433
Brief 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.
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.
Study:
NCT01590433
Study Brief:
Protocol Section:
NCT01590433