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Very Low Calorie Diet for Diabetic Kidney Disease

Primary Purpose

Diabetic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
very low calorie diet
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring determine effects of diet on renal and other parameters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

very low calorie diet

Arm Description

Outcomes

Primary Outcome Measures

Urinary albumin excretion

Secondary Outcome Measures

Full Information

First Posted
March 20, 2012
Last Updated
August 27, 2015
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01671969
Brief Title
Very Low Calorie Diet for Diabetic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
determine effects of diet on renal and other parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
very low calorie diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
very low calorie diet
Intervention Description
medically supervised diet
Primary Outcome Measure Information:
Title
Urinary albumin excretion
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23929927
Citation
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.
Results Reference
derived

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Very Low Calorie Diet for Diabetic Kidney Disease

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