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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT00691158
Eligibility Criteria:
Inclusion Criteria:
* Age 18 year to 45 years of age
* MI 18 to 25 kg/m2 or ≥ 30 kg/m2
* At maximal lifetime weight
* Weight stable for at least 3 months
Exclusion Criteria:
* Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
* Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:
* depression
* anorexia
* bulimia
* seizure disorder.
* Exercise \> 30 minutes, 3 times a week
* Alcohol consumption \> 2 drinks / day
* Weight \> 350 lbs (159 kg) (weight limit for MR machine)
* Illicit drug use
* Pregnancy
* Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes
* Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
* Those with claustrophobia
* Anaphylaxis and known hypersensitivity to E. coli-derived proteins
* Allergies or contraindications to metreleptin or pramlintide
* Renal or hepatic impairment
* Women who are lactating
* Tobacco use
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00691158
Study Brief:
Protocol Section:
NCT00691158