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
About this trial
This is an interventional diagnostic trial for Kidney Diseases focused on measuring glomerular hyperfiltration, proteinuria
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
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
NCT ID
NCT00244790
First Posted
October 25, 2005
Last Updated
August 26, 2015
Sponsor
Indiana University School of Medicine
Collaborators
National Institutes of Health (NIH)
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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