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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00996294
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus
* Duration of diabetes ≥ 3 years
* Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)
Exclusion Criteria:
* Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
* Pregnancy
* Medical conditions requiring acute hospitalisation
* Severe diabetes complications or associated medical conditions \[such as blindness, end-stage renal failure (i.e. serum creatinine \>2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)\]
* 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 judgment 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:
NCT00996294
Study Brief:
Protocol Section:
NCT00996294