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The Effects of Obesity and Protein Intake on the Kidney

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00244790
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : August 28, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Kidney Diseases Behavioral: Diet

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Effects of Obesity and Protein Intake on the Kidney
Study Start Date : April 2004
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: low protein Behavioral: Diet
crossover low vs high protein diet before and after weight loss
Other Names:
  • Diet 1
  • Diet 2

Outcome Measures

Primary Outcome Measures :
  1. glomerular filtration rate [ Time Frame: days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244790

United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46122
Sponsors and Collaborators
Indiana University School of Medicine
National Institutes of Health (NIH)
Principal Investigator: Allon Friedman, MD Indiana University
More Information

Responsible Party: Allon Friedman, MD, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00244790     History of Changes
Other Study ID Numbers: 0309-03
K23RR019615-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Allon Friedman, MD, Indiana University:
glomerular hyperfiltration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases