The Effects of Obesity and Protein Intake on the Kidney

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allon Friedman, MD, Indiana University
ClinicalTrials.gov Identifier:
NCT00244790
First received: October 25, 2005
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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 Intervention
Kidney Diseases
Behavioral: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: The Effects of Obesity and Protein Intake on the Kidney

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • glomerular filtration rate [ Time Frame: days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2004
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low protein Behavioral: Diet
crossover low vs high protein diet before and after weight loss
Other Names:
  • Diet 1
  • Diet 2

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244790

Locations
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46122
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Allon Friedman, MD Indiana University
  More Information

No publications provided

Responsible Party: Allon Friedman, MD, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00244790     History of Changes
Other Study ID Numbers: 0309-03, K23 RR019615-01A1
Study First Received: October 25, 2005
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Indiana University:
glomerular hyperfiltration
proteinuria

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014