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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT03891056
Eligibility Criteria:
Inclusion Criteria:
* Both sex patients aged between 18 and 65 years old
* Class I obesity (BMI 30-35 kg/m2) with bad metabolic control (DM-2 with HbA1c \> 7,5%) and non-insulin anti-diabetic treatment failure (it is necessary \>10 years of known diabetes evolution time, C-peptideā„ 1 ng/ml, no insulin treatment, at least two oral hypoglycemic agents treatment);
* Patients who accomplish the follow-up protocol designed by both Surgery and Endocrinology departments
* Informed consent signed
Exclusion Criteria:
* Patients who do not accomplish the previosly described inclusion criteria; Patient's refusal to take part in the study; Patients with symptomatology of gastroesophageal reflux disease or with upper gastrointestinal series compatible with this desease.
Previous bariatric surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03891056
Study Brief:
Protocol Section:
NCT03891056