The Effects of Obesity and Protein Intake on the Kidney

• Sponsor: Indiana University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00244790
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 120
• Patients Per Site Per Month: 0.4

Study Details

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	Phase
Kidney Diseases	Behavioral: Diet	N/A

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
• 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: Apr 1, 2004
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

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 [days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Indianapolis	Indiana	United States	46122

Sponsors and Collaborators

• Indiana University School of Medicine
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Allon Friedman, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allon Friedman, MD, MD, Indiana University
• ClinicalTrials.gov Identifier: NCT00244790
• Other Study ID Numbers: 0309-03; K23RR019615-01A1
• First Posted: Oct 27, 2005
• Last Update Posted: Aug 28, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Allon Friedman, MD, MD, Indiana University: glomerular hyperfiltration; proteinuria
• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Aug 28, 2015