- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00067678
Soy Protein in Early Diabetic Nephropathy
August 16, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age 18-40;
- Diabetic nephropathy;
- Type I diabetes mellitus.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paolo Fanti, MD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
August 25, 2003
First Submitted That Met QC Criteria
August 26, 2003
First Posted (Estimate)
August 27, 2003
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 16, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000323-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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