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

This study has been completed.
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00555490
First received: November 7, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention Phase
Kidney Transplantation
Dietary Supplement: Soy protein
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • mortality or using dialysis [ Time Frame: 4-years ]

Enrollment: 41
Study Start Date: April 2001
Study Completion Date: September 2005
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Soy protein
35 % of protein from soy protein for 4-years

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

  • Dialysis
  • Transplantation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00555490

Sponsors and Collaborators
Isfahan University of Medical Sciences
Shahid Beheshti Medical University
Investigators
Principal Investigator: Leila Azadbakht, PhD Isfahan University of Medical Sciences, School of Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00555490     History of Changes
Other Study ID Numbers: IsfahanUMS
Study First Received: November 7, 2007
Last Updated: November 7, 2007
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Soy
Diabetes
Nephropathy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014