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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
History of Changes
  Purpose

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


Condition Intervention
Diabetic Kidney Disease
 Other: very low calorie diet

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Urinary albumin excretion [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: very low calorie diet Other: very low calorie diet
medically supervised diet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671969

Locations
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01671969     History of Changes
Other Study ID Numbers: VLCD1
Study First Received: March 20, 2012
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
determine effects of diet on renal and other parameters

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013