Very Low Calorie Diet for Diabetic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01671969
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : August 28, 2015
Information provided by (Responsible Party):
Indiana University

March 20, 2012
August 24, 2012
August 28, 2015
March 2012
March 2014   (Final data collection date for primary outcome measure)
Urinary albumin excretion [ Time Frame: 3 months ]
Change in weight [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01671969 on Archive Site
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Very Low Calorie Diet for Diabetic Kidney Disease
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The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.
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Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetic Kidney Disease
Other: very low calorie diet
medically supervised diet
Experimental: very low calorie diet
Intervention: Other: very low calorie diet
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Indiana University
Indiana University
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Indiana University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP