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Related Studies
Soy Protein in Early Diabetic Nephropathy
This study has been completed.
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00067678
  Purpose

Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary protein has been used to slow down renal disease progression, but patients are often unwilling to make these dietary changes. Other research suggests that changing the quality of dietary protein may be as effective as reducing the total amount of ingested protein. This study hopes to show that soy protein, a plant protein relatively high in essential amino acids and with high nutritional value, maye be beneficial to Type I diabetic patients with incipient renal disease.


Condition Intervention Phase
Diabetic Nephropathy
Diabetes Mellitus
Drug: soy protein
Phase I
Phase II

MedlinePlus related topics: Diabetes Diabetic Kidney Problems
Drug Information available for: Proteins, soy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Soy Protein in Early Diabetic Nephropathy

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: July 2001
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 18-40;
  • Diabetic nephropathy;
  • Type I diabetes mellitus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067678

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Investigators
Principal Investigator: Paolo Fanti, MD University of Kentucky
  More Information

No publications provided

Study ID Numbers: R21 AT000323-01
Study First Received: August 25, 2003
Last Updated: August 16, 2006
ClinicalTrials.gov Identifier: NCT00067678  
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
diabetic nephropathy
nephropathy
diabetes
diabetes mellitus
type I diabetes
soy protein

Study placed in the following topic categories:
Metabolic Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Mellitus, Type 1
Diabetes mellitus type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on February 12, 2009