Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00856609
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : January 12, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date  ICMJE March 5, 2009
First Posted Date  ICMJE March 6, 2009
Results First Submitted Date  ICMJE September 18, 2017
Results First Posted Date  ICMJE January 12, 2018
Last Update Posted Date June 4, 2019
Study Start Date  ICMJE March 3, 2009
Actual Primary Completion Date September 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Energy Intake [ Time Frame: Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention) ]
    Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups
  • Twenty-four-hour Energy Expenditure [ Time Frame: Day 5 and Day 11 ]
    Change of twenty-four-hour energy expenditure between at Day 5 at baseline assessment and at Day 11 two days after starting study medication between the exenatide and placebo groups
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
Exenatide effects on wt loss, enerfy expenditure & food intake
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
Body Weight [ Time Frame: 5 weeks ]
Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
Weight loss maintenance, decreased fat mass, decreased food intake and increased energy expenditure with extended exenatide treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects
Official Title  ICMJE The Effects of Exenatide (Byetta) on Energy Expenditure and Weight Loss in Non-Diabetic Obese Subjects
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Weight Loss
  • Obesity
Intervention  ICMJE
  • Drug: Byetta (exenatide)
    Exenatide is an injectable medication
  • Behavioral: Weight loss
    Because response to weight loss
  • Other: Metabolic Chamber
    The subject stays in the small room
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Exenatide
    10 micrograms subcutaneously twice
    Interventions:
    • Drug: Byetta (exenatide)
    • Behavioral: Weight loss
  • Placebo Comparator: Placebo
    Twice daily
    Interventions:
    • Other: Metabolic Chamber
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)
150
Original Enrollment  ICMJE
 (submitted: March 5, 2009)
100
Actual Study Completion Date  ICMJE September 19, 2016
Actual Primary Completion Date September 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:
  • Premenopausal women and men < 55 years of age
  • BMI >30 kg/m(2)
  • Expressed desire for weight loss
  • Stable weight (variation < 2.3 kg within past 6 months)
  • Ability to provide informed consent
  • Ability to follow verbal and written instructions
  • Nonsmoker
  • Ability to commute to study site on a regular basis for short outpatient visits over 5 weeks
  • For females, use of a medically approved form of contraception. For oral contraceptives, subjects will need to be on an established dose for at least 3 months to ensure stable weight and will be asked not to switch contraceptive methods during study participation.

EXCLUSION CRITERIA:

  • Age < 18 years
  • Use of other medications to treat obesity including medications obtained over the counter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), topiramate (with or without phentermine (Qsymia), phentermine (Adipex P) or lorcaserin (Belviq) within the past 6 months
  • History of an eating disorder including anorexia or bulimia
  • History of surgery for the treatment of obesity (gastric banding, gastric bypass)
  • Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association guidelines
  • Previous exposure to exenatide
  • Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or more occasions or use of antihypertensive medications which may affect energy expenditure including alpha blockers, beta blockers, angiotensin receptor blockers or inhibitors of angiotensin converting enzyme
  • Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous drug use
  • Chronic ethanol use (> 3 drinks /day)
  • Endocrine disorders including hypo or hyperthyroidism (including subclinical disease), Cushing s disease, growth hormone deficiency or other pituitary diseases
  • History of pancreatitis
  • Personal or family history of multiple endocrine neoplasia (MEN)-2 or medullary thyroid cancer
  • History of unresolved gallstones
  • Hyperamylasemia
  • Fasting triglyceride level greater than or equal to 500
  • Gastroparesis
  • Inflammatory bowel disease or malabsorption disorders
  • Malignancy treated with chemotherapy or radiation within the past 5 years
  • Current clinical depression, diagnosis of psychosis or recent use of psychotropic medication
  • Pregnancy within past 6 months
  • Breastfeeding
  • Failure to use medically approved contraceptive methods if subject is female
  • Liver function abnormalities (transaminases greater than twice normal)
  • Renal insufficiency (creatinine clearance < 50 ml/min)
  • History of chronic infection including tuberculosis, coccidiomycoses, lyme disease or HIV infection
  • Pulmonary disorders, including chronic obstructive pulmonary disease, which would limit ability to follow the protocol (investigator judgment)
  • Cardiovascular disease including history of myocardial infarction, unstable angina or heart failure
  • Central nervous system disease, including history of cerebrovascular accidents, dementia, and neurodegenerative disorders
  • Weight <450 pounds (maximum weight of the DXA machine as per manufacturer s manual)
  • Sensitivity to exenatide or any inert components in its formulation
  • Sensitivity to acetaminophen
  • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00856609
Other Study ID Numbers  ICMJE 999909095
09-DK-N095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Krakoff, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 19, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP