NCT00244790

Brief Summary

The purpose of this study is to determine if being overweight and eating lots of protein causes separate changes in the kidney that lead to kidney disease over time. These questions are important because the number of people who have kidney disease is quickly growing. If being overweight and eating lots of protein is found to cause kidney disease, then doctors may be able to limit the number of people with kidney disease by recommending weight loss and eating less protein

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

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

April 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

10 years

First QC Date

October 25, 2005

Last Update Submit

August 26, 2015

Conditions

Kidney Diseases

Keywords

glomerular hyperfiltrationproteinuria

Outcome Measures

Primary Outcomes (1)

  • glomerular filtration rate

    days

Study Arms (1)

low protein

EXPERIMENTAL
Behavioral: Diet

Interventions

DietBEHAVIORAL

crossover low vs high protein diet before and after weight loss

Also known as: Diet 1, Diet 2
low protein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 18 years of age
  • Ability to give informed consent
  • Not pregnant and using appropriate contraceptive methods, or not of childbearing potential
  • BMI of 30 or higher

You may not qualify if:

  • Iodine or shellfish allergy
  • History of adverse reaction to intravenous contrast
  • Dialysis dependence
  • Diagnosis of diabetes mellitus or taking medicine for diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Indianapolis, Indiana, 46122, United States

Location

MeSH Terms

Conditions

Kidney DiseasesProteinuria

Interventions

Diet

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Allon Friedman, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

April 1, 2004

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

US(1)