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

Kidney Transplantation Clinical Trial

Official title:

Soy-Protein Intake, Cardio-Renal Indices and C-Reactive Protein in Type 2 Diabetes With Nephropathy: a 4-y Randomized Clincal Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555490
• Other study ID #: IsfahanUMS
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2007
• Last updated: November 7, 2007
• Start date: April 2001
• Est. completion date: September 2005

Study information

• Verified date: November 2007
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

• Dialysis

• Transplantation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Transplantation

Intervention

Dietary Supplement:
• Soy protein
35 % of protein from soy protein for 4-years

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences	hahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality or using dialysis		4-years