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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01671969
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes
* Age \> 18
* Body mass index ≥ 30
* Presumed or biopsy-proven diabetic nephropathy
* Estimated GFR \< 40 ml/min/1.73 meters squared
* Proteinuria \> 0.5 gm/day
* Motivated to lose weight
* Stable medical co-morbidities
* Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated)
Exclusion Criteria:
* Inability to sign informed consent
* Life expectancy of \< 1 year
* Expected need for initiation of dialysis within 9 months
* Type 1 Diabetes
* Recent myocardial infarction or stroke (past 3 months)
* Unstable angina
* Active cancer
* Pregnancy/lactation
* Serious psychiatric diseases
* Substance abuse
* Uncontrolled hypertension (\> 180/110)
* Ineligible for VLCD based on laboratory data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01671969
Study Brief:
Protocol Section:
NCT01671969