Soy Protein in Early Diabetic Nephropathy

This study has been completed.

First Received: August 25, 2003 Last Updated: August 16, 2006 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Soy Protein in Early Diabetic Nephropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Kidney Problems

Drug Information available for: Proteins, soy

U.S. FDA Resources

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

National Center for Complementary and Alternative Medicine (NCCAM)

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 History of Changes
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

Additional relevant MeSH terms:

Metabolic Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Mellitus

Endocrine System Diseases
Kidney Diseases
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009