Back to resultsSoy Protein in Early Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathy, Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
soy protein
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring diabetic nephropathy, nephropathy, diabetes, diabetes mellitus, type I diabetes, soy protein
Eligibility Criteria
Inclusion criteria: Age 18-40; Diabetic nephropathy; Type I diabetes mellitus.
Sites / Locations
- University of Kentucky
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00067678
First Posted
August 25, 2003
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00067678
Brief Title
Soy Protein in Early Diabetic Nephropathy
Official Title
Soy Protein in Early Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Diabetes Mellitus
Keywords
diabetic nephropathy, nephropathy, diabetes, diabetes mellitus, type I diabetes, soy protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
soy protein
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 18-40;
Diabetic nephropathy;
Type I diabetes mellitus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Fanti, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
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Soy Protein in Early Diabetic Nephropathy
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