Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2012-03-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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very low calorie diet
very low calorie diet
medically supervised diet
Interventions
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very low calorie diet
medically supervised diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Locations
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University Hospital
Indianapolis, Indiana, United States
Countries
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References
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Friedman AN, Chambers M, Kamendulis LM, Temmerman J. Short-term changes after a weight reduction intervention in advanced diabetic nephropathy. Clin J Am Soc Nephrol. 2013 Nov;8(11):1892-8. doi: 10.2215/CJN.04010413. Epub 2013 Aug 8.
Other Identifiers
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VLCD1
Identifier Type: -
Identifier Source: org_study_id
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