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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT01046994
Eligibility Criteria:
Inclusion Criteria:
* age: 35-70 years
* diabetes duration: \>5 years
* documented poor glycemic control (HbA1c =\>8% despite medical treatment according to GCP)
* presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
* availability to comply with the entire follow-up
Exclusion Criteria:
* general contraindications to BPD (applies also to medical controls)
* presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration \<0.5 mcg/L
* blindness
* severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
* heart failure
* recent history (less than 12 months) of myocardial infarction, stroke or TIA
* unstable angina
* pregnancy
* previous or concomitant malignancy
* severe active inflammatory, neurologic, or cardiovascular conditions
* geographic inaccessibility
* any condition which, in the opinion of the Principal 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:
NCT01046994
Study Brief:
Protocol Section:
NCT01046994