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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT01094756
Eligibility Criteria:
Inclusion Criteria:
* 41 obese adults (BMI 33 kg - 45 kg.)
* 24 lean adults (BMI 18.5 kg - 24.9 kg.)
Exclusion Criteria:
* Subjects who are:
1. smokers,
2. pregnant or lactating, postmenopausal,
3. have diabetes or impaired oral glucose tolerance (fasting blood glucose level of \< 100 mg/dl and a 2 hour post-glucose challenge plasma glucose level of \< 140mg/dl, per ADA criteria; ADA 2004),
4. significant organ system dysfunction, anemia (Hb \<10 g/dl),
5. take medications that could influence the study results, any history of dopamine agonist or antagonist treatment (e.g. neuroleptics or metoclopramide),
6. parkinsonism on exam,
7. borderline or lower IQ (\<80 full scaled score), or
8. any psychiatric or neurologic illness (e.g. drug abuse, Parkinson disease, Tourette syndrome, stroke) that could affect the interpretation of the data, compliance or completion of the study will be excluded. Specific psychiatric exclusions are lifetime psychosis, current mania, substance dependence, major depression, social phobia, tic disorders, eating disorders and panic disorder. Dysthymia will not be excluded, but levels of depression will be measured with the BDI for future exploratory analysis.
* Lean subjects will be excluded for being obese in the past (based on maximum BMI not related to pregnancy).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01094756
Study Brief:
Protocol Section:
NCT01094756