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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01041768
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥30 and ≤34.9 kg/m2
* age between 35 and 70 years
* duration of diabetes ≥ 5 years
* poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
* presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
Exclusion Criteria:
* specific contraindication to obesity surgery or GBP or BPD, including any gastric alteration specifically contraindicating GBP
* HbA1c \< 8%
* positive autoantibodies anti-pancreas islet
* serum C-peptide \< 0.5 ng/ml
* pregnancy
* medical conditions requiring acute hospitalisation
* severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure
* recent (within preceding 12 months) myocardial infarction, stroke or TIA
* unstable angina pectoris
* psychological conditions which may hamper patient's cooperation
* geographic inaccessibility
* any condition which, in the judgement of the Investigator, may make risky the participation in the study or bias the results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT01041768
Study Brief:
Protocol Section:
NCT01041768