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Completed

NCT Number: NCT00244790

The Effects of Obesity and Protein Intake on the Kidney

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

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Indianapolis, Indiana, 46122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

crossover low vs high protein diet before and after weight loss

Other names: Diet 1, Diet 2

Primary outcomes

  1. glomerular filtration rate

    Time frame: days

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Oct 27, 2005
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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