NCT00067678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2003

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

August 25, 2003

Last Update Submit

August 16, 2006

Conditions

Diabetic NephropathyDiabetes Mellitus

Keywords

diabetic nephropathynephropathydiabetesdiabetes mellitustype I diabetessoy protein

Interventions

soy proteinDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40;
  • Diabetic nephropathy;
  • Type I diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusKidney DiseasesDiabetes Mellitus, Type 1

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Paolo Fanti, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 25, 2003

First Posted

August 27, 2003

Study Start

July 1, 2001

Study Completion

June 1, 2003

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)