Soy Protein in Early Diabetic Nephropathy - Tabular View

Tracking Information

First Received Date ^ICMJE

August 25, 2003

Last Updated Date

August 16, 2006

Start Date ^ICMJE

July 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00067678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Soy Protein in Early Diabetic Nephropathy

Official Title ^ICMJE

Soy Protein in Early Diabetic Nephropathy

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetic Nephropathy
Diabetes Mellitus

Intervention ^ICMJE

Drug: soy protein

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Age 18-40;
Diabetic nephropathy;
Type I diabetes mellitus.

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067678

Responsible Party

Study ID Numbers ^ICMJE

R21 AT000323-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Paolo Fanti, MD

University of Kentucky

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP