The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects
Condition: Weight Loss; Obesity
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      Exenatide is an incretin-like drug that has been approved for treatment of type 2 diabetes;
      it improves glycemia by increasing insulin and decreasing glucagon secretion by pancreatic
      islet cells and delaying gastric emptying. This randomized, placebo-controlled study is to
      evaluate whether exenatide over a 5 week period in non-diabetic obese subjects may lead to
      weight loss. To control for variability in individual response to weight loss treatment, this
      study will assess the role of exenatide in changing food intake and energy expenditure as
      possible sources of weight loss. This study will also evaluate the safety profile of
      exenatide in non-diabetic obese people. Additional assessments will evaluate changes in body
      fat and hormones involved in the sensations of hunger and fullness.
    

Detailed description: 
      Obesity can lead to a number of health problems including diabetes, heart disease, stroke,
      low back pain, fatty liver disease, and osteoarthritis. The medical treatments currently
      available for obesity are limited. Exenatide is an injectable medication approved for
      treatment of type 2 diabetes that causes weight loss in some diabetic subjects. The reasons
      exenatide is thought to cause weight loss include decreased food intake, increased feelings
      of fullness and nausea. Because levels of a human gut hormone (glucagon like peptide 1) that
      is similar to exenatide have been shown to be related to resting energy expenditure, it is
      also possible that exenatide may have effects on a person s metabolism, a.k.a. energy
      expenditure, but any effect of exenatide on energy expenditure has yet to be evaluated. Even
      though exenatide is used to treat diabetes, administration of exenatide to non-diabetic lean
      individuals did not cause frankly low blood sugars.

      The primary goal of this study is to investigate the way in which exenatide given twice a day
      to obese (BMI >= 30 kg/m^2) people without diabetes might lead to weight loss. Because
      response to weight loss treatment can be highly variable between individuals, we will look at
      the role of exenatide in changing food intake and energy expenditure as possible explanations
      for weight loss. We will also assess the safety profile of exenatide in non-diabetic obese
      people.

      This study will involve the use of exenatide or placebo, determined randomly, in obese
      individuals without diabetes over a 5 week period. The primary measurements will include
      effects of exenatide on energy expenditure and food intake. We will also look at changes in
      body fat and the levels of hormones involved in the sensations of hunger and fullness. We
      will assess if any exenatide-induced changes can predict which individuals lose weight over
      the 5 weeks. The safety and side effects of exenatide in non-diabetic individuals during this
      time will also be determined. Findings from this study would help to determine how exenatide
      works to cause weight loss in people without diabetes, who might benefit most, and would help
      to improve understanding of why some people respond better to weight loss treatment than
      others.
    

Intervention name(s): Byetta (exenatide); Weight loss; Metabolic Chamber; Placebo
Intervention type(s): Drug; Behavioral; Other; Drug
Intervention description(s): Exenatide is an injectable medication; Because response to weight loss; The subject stays in the small room
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Weight Loss; Byetta (Exenatide); Energy Expenditure; Food Intake; Obesity