The Effects of Obesity and Protein Intake on the Kidney

Kidney Diseases Clinical Trial

Official title:

The Effects of Obesity and Protein Intake on the Kidney

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244790
• Other study ID #: 0309-03
• Secondary ID: K23RR019615-01A1
• Status: Completed
• Phase: N/A
• First received: October 25, 2005
• Last updated: August 26, 2015
• Start date: April 2004
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Behavioral:
• Diet
crossover low vs high protein diet before and after weight loss

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glomerular filtration rate		days	No