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:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01834404
Eligibility Criteria:
INCLUSION CRITERIA:
* Obese subjects with BMI\> 30 Kg/m\^2. Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
* Women of childbearing potential will have negative pregnancy test before initiation of medication.
EXCLUSION CRITERIA:
* Weight \>300 lbs, which is the limit of safety for the SPECT scanner
* Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)
* Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)
* Concentration of fasting glucose greater than 240 mg/dl
* Concentration of triglycerides greater than 400 mg/dl
* Type 1 Diabetes
* Use of anti-diabetic drugs other than metformin,
* History of nephrolithiasis,
* Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire-9, 21 total score ≥10).
* Concomitant use of Monoamine Oxidase Inhibitors (MAOI) (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants
* Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale \[HADS\] self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety and Depression Scale (HADS) score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
* End stage renal disease or liver cirrhosis
* Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01834404
Study Brief:
Protocol Section:
NCT01834404