- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00244790
The Effects of Obesity and Protein Intake on the Kidney
August 26, 2015 updated by: Allon Friedman, MD, Indiana University School of Medicine
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46122
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low protein
|
crossover low vs high protein diet before and after weight loss
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glomerular filtration rate
Time Frame: days
|
days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Allon Friedman, MD, Indiana University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
October 25, 2005
First Submitted That Met QC Criteria
October 25, 2005
First Posted (Estimate)
October 27, 2005
Study Record Updates
Last Update Posted (Estimate)
August 28, 2015
Last Update Submitted That Met QC Criteria
August 26, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0309-03
- K23RR019615-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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