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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 14, 2014