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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02778269
Eligibility Criteria:
Inclusion Criteria:
1. Insulin-treated diabetes mellitus (type 1 or 2)
2. CKD with eGFR \< 45 ml/min, determined using the Modification of Diet in Renal Disease (MDRD) formula
3. Stable anti-diabetic and cardiac medication prior to inclusion
4. Male aged ≥ 18 years
5. Written informed consent prior to study participation
6. Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel.
Exclusion Criteria:
1. Pregnancy or women without sufficient contraception, adapted specifically to amenorrhoeic hemodialysis patients
2. Life expectancy below 6 months
3. Participation in another clinical trial within the previous 2 months
4. History of any other illness, which, in the opinion of the investigator, might pose an unacceptable risk when administering study medication
5. Any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
6. Alcohol or drug abuse
7. Patient has been committed to an institution by legal or regulatory order
8. Patients with any kind of pacemakers
9. Expected non-compliance
10. Patients unwilling or unable to give informed consent, or with limited ability to comply with instructions for this study
11. Participation in a parallel interventional clinical trial
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02778269
Study Brief:
Protocol Section:
NCT02778269