The Effects of Obesity and Protein Intake on the Kidney

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2014-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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low protein

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

crossover low vs high protein diet before and after weight loss

Interventions

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Diet

crossover low vs high protein diet before and after weight loss

Intervention Type BEHAVIORAL

Other Intervention Names

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Diet 1 Diet 2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes