Phase
Condition
Diabetes Prevention
Obesity
Weight Loss
Treatment
N/AClinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 5weeks
For females, use of a medically approved form of contraception. For oralcontraceptives, subjects will need to be on an established dose for at least 3 monthsto ensure stable weight and will be asked not to switch contraceptive methods duringstudy participation.
Exclusion
EXCLUSION CRITERIA:
Age < 18 years
Use of other medications to treat obesity including medications obtained over thecounter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), topiramate (withor without phentermine (Qsymia), phentermine (Adipex P) or lorcaserin (Belviq) withinthe 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 DiabetesAssociation guidelines
Previous exposure to exenatide
Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or moreoccasions or use of antihypertensive medications which may affect energy expenditureincluding alpha blockers, beta blockers, angiotensin receptor blockers or inhibitorsof angiotensin converting enzyme
Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous druguse
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 medullarythyroid 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 psychotropicmedication
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 orHIV infection
Pulmonary disorders, including chronic obstructive pulmonary disease, which wouldlimit ability to follow the protocol (investigator judgment)
Cardiovascular disease including history of myocardial infarction, unstable angina orheart 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 thediscretion of the investigators
Study Design
Study Description
Connect with a study center
NIDDK, Phoenix
Phoenix, Arizona 85014
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.