Soy Protein in Early Diabetic Nephropathy

• Sponsor: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00067678
• Collaborator: (none)
• Location: 1
• Duration (Months): 23

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy; Diabetes Mellitus	Drug: soy protein	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Soy Protein in Early Diabetic Nephropathy
• Study Start Date: Jul 1, 2001
• Study Completion Date: Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Age 18-40;

• Diabetic nephropathy;

• Type I diabetes mellitus.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Paolo Fanti, MD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00067678
• Other Study ID Numbers: R21AT000323-01
• First Posted: Aug 27, 2003
• Last Update Posted: Aug 18, 2006
• Last Verified: Aug 1, 2006

• Keywords provided by , ,: diabetic nephropathy; nephropathy; diabetes; diabetes mellitus; type I diabetes; soy protein
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus

Study Results

No Results Posted as of Aug 18, 2006