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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01748994
Eligibility Criteria:
Inclusion Criteria:
* You are a pre-menopausal woman between 18-40 years of age
* Your Body Mass Index (BMI, weight-to-height2 ratio) is 27 - 38 kg/m2, inclusive
* The ratio of your waist-to-hip circumferences is either \>0.84 ("apple"-type body shape) or \<0.77 ("pear"-type body shape)
* You are willing to undergo a drug intervention for 16 weeks
* You are willing to drink heavy water \[similar to the ordinary water that is highly enriched in the naturally occurring stable (non-radioactive) form of hydrogen, deuterium; also called deuterium-labeled water\] for 8 weeks before the beginning and during the second half of the drug intervention; you will need 24-hours access to a refrigerator for storage of the water.
* You agree to use a double barrier method as a form of birth control to prevent pregnancy. Oral contraceptives (birth control pills) are not allowed in the study. Acceptable methods of birth control are condoms, spermicide, IUD (intrauterine device, must be hormone free - see list in clinic), diaphragm and abstinence. An example of a double barrier method would be condoms plus spermicide, etc.
Exclusion Criteria:
* You have gained or lost more than 4.5 lb (2 kg) in the last 3 months
* You have had significant changes in the diet or level of physical activity within the past month
* You have a blood sugar of greater than 100 or a diagnosis of diabetes.
* You have abnormal liver enzyme values from your blood work
* You have a history of heart, kidney, lung, liver, and thyroid disease
* You have an average blood pressure \>140/90 at your screening visit
* Have you had a positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C?
* You require chronic use of medications including diuretics, steroids, thyroid hormones, and adrenergic-stimulating agents (bronchodilators, nasal decongestants)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01748994
Study Brief:
Protocol Section:
NCT01748994