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The Effects of Obesity and Protein Intake on the Kidney

Primary Purpose

Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Diseases focused on measuring glomerular hyperfiltration, proteinuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Iodine or shellfish allergy History of adverse reaction to intravenous contrast Dialysis dependence Diagnosis of diabetes mellitus or taking medicine for diabetes mellitus

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low protein

Arm Description

Outcomes

Primary Outcome Measures

glomerular filtration rate

Secondary Outcome Measures

Full Information

First Posted
October 25, 2005
Last Updated
August 26, 2015
Sponsor
Indiana University School of Medicine
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00244790
Brief Title
The Effects of Obesity and Protein Intake on the Kidney
Official Title
The Effects of Obesity and Protein Intake on the Kidney
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
The purpose of this study is to test the hypothesis that being obese leads to changes in kidney function that are independent of, and enhanced by, high dietary protein intake. Kidney function will be measured by the kidney's ability to filter blood and by the amount of protein in the urine. The hypothesis will be tested in the following manner: The first part of the study will involve a crossover design comparing kidney function in obese people with stable weights on a low and high protein diet ("Low/High Protein Study"). The second part of the study will compare kidney function in obese people before and after weight reduction surgery ("Before/After Surgery Study"). Since certain changes in kidney function may lead to kidney disease over time, it is important to confirm the effects of obesity and dietary protein intake on the kidney, especially with the current rise in obese people and the popularity of high protein diets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
glomerular hyperfiltration, proteinuria

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low protein
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Diet
Other Intervention Name(s)
Diet 1, Diet 2
Intervention Description
crossover low vs high protein diet before and after weight loss
Primary Outcome Measure Information:
Title
glomerular filtration rate
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Iodine or shellfish allergy History of adverse reaction to intravenous contrast Dialysis dependence Diagnosis of diabetes mellitus or taking medicine for diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allon Friedman, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46122
Country
United States

12. IPD Sharing Statement

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The Effects of Obesity and Protein Intake on the Kidney

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