Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00555490
• Collaborator: Shahid Beheshti University of Medical Sciences (Other)
• Enrollment: 41
• Arm: 1
• Duration (Months): 53

Study Details

Study Description

Brief Summary

we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic patients with nephropathy.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Dietary Supplement: Soy protein	Phase 1

Detailed Description

Background: Several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy.

Objectives: To determine the effects of long-term soy consumption on cardiovascular risks, C-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy.

Design: This longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). Twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Soy-Protein Intake, Cardio-Renal Indices and C-Reactive Protein in Type 2 Diabetes With Nephropathy: a 4-y Randomized Clincal Trial
• Study Start Date: Apr 1, 2001
• Actual Study Completion Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Dietary Supplement: Soy protein; 35 % of protein from soy protein for 4-years

Outcome Measures

Primary Outcome Measures

1. mortality or using dialysis [4-years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

• Dialysis

• Transplantation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Isfahan University of Medical Sciences
• Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Leila Azadbakht, PhD, Isfahan University of Medical Sciences, School of Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00555490
• Other Study ID Numbers: IsfahanUMS
• First Posted: Nov 8, 2007
• Last Update Posted: Nov 8, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: Soy; Diabetes; Nephropathy
• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Nov 8, 2007