Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT01590433
Eligibility Criteria:
Inclusion Criteria:
* Females age 18-70
* BMI 28-48 kg/m\^2
* Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
* Ability to give informed consent and follow verbal and written instructions in English.
Exclusion Criteria:
* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
* Unstable heart disease as evidenced by ongoing angina
* Congestive heart failure
* Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
* Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
* Tobacco, marijuana, cocaine, or intravenous drug use
* Shift workers (night shift or alternating day/night shifts)
* Gastroparesis
* Inflammatory bowel disease or irritable bowel syndrome
* Malignancy treated with chemotherapy within the past 3 years
* History of pancreatitis
* Depression requiring hospitalization or diagnosis of psychosis
* Renal insufficiency (eGFR less than 50)
* Transaminases greater than 2 times above the normal range
* Pregnancy within 6 months of the screening visit
* Lactation
* Failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
* History of an eating disorder (anorexia, bulimia or laxative abuse)
* Treatment with FDA-approved or over-the-counter weight loss medication within 6 months, with the exception of Xenical if there was no weight loss
* History of gastric bypass surgery or gastric stapling
* Biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit
* Previous treatment with exenatide
* Discretion of the PI
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01590433
Study Brief:
Protocol Section:
NCT01590433