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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT01494168
Eligibility Criteria:
Inclusion criteria:
* BMI \> 40 kg/m2 or BMI 35-40 with major comorbidities
* Age between 18-60 years
* Obesity evolving for more than 5 years
* Failure of medical treatment
* Elimination of hormonal causes
Exclusion criteria:
* Uncontrolled hypertension (SBP \> 160 mmHg and DBP\> 100 mmHg).
* History of cardiovascular disease or signs of clinical atheroma: stroke, myocardial infarction and coronary heart disease (angina), peripheral arterial disease (no pulse, claudication), aortic aneurysm (anterior abdominal palpation or imaging ), carotid bruit
* Plasma creatinine \> 130 micromol/L and/or proteinuria \> 300 mg/24 h and/or dipstick hematuria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01494168
Study Brief:
Protocol Section:
NCT01494168