Very Low Calorie Diet for Diabetic Kidney Disease
Not Applicable
Completed
- Conditions
- Diabetic Kidney Disease
- Registration Number
- NCT01671969
- Lead Sponsor
- Indiana University
- Brief Summary
The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Urinary albumin excretion 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇺🇸Indianapolis, Indiana, United States
University Hospital🇺🇸Indianapolis, Indiana, United States