Very Low Calorie Diet for Diabetic Kidney Disease

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01671969
First received: March 20, 2012
Last updated: April 1, 2013
Last verified: March 2013

March 20, 2012
April 1, 2013
March 2012
March 2014   (final data collection date for primary outcome measure)
Urinary albumin excretion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01671969 on ClinicalTrials.gov Archive Site
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Very Low Calorie Diet for Diabetic Kidney Disease
Not Provided

The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01671969
VLCD1
No
Indiana University
Indiana University
Not Provided
Not Provided
Indiana University
March 2013

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