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Behavioural Intervention

Weight Loss for Kidney Stones

N/A

Recruiting

Led By Dean Assimos, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

First time or recurrent calcium oxalate stone formers defined as composition of most recent stone >50% calcium oxalate without uric acid component

24-hour urine collection with creatinine within 20% of gender appropriate (mg creat/kg body weight) and consistent between collections (within 20% of each other)

Must not have

Uncontrolled hypertension, myocardial infarction in past 6 months, unstable angina, congestive heart failure

Cirrhosis, pancreatic or biliary disorder, porphyria, gout

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if weight loss can help reduce the amount of oxalate produced by the body, which may help prevent calcium oxalate kidney stones.

Who is the study for?

This trial is for obese individuals with a BMI over 35 who have had calcium oxalate kidney stones but no stone issues in the last 3 months. Participants must not have diabetes, severe dyslipidemia, or recent surgery and should be willing to follow specific dietary guidelines and avoid certain medications.

What is being tested?

The study tests if the Optifast VLCD weight loss program can reduce endogenous oxalate synthesis contributing to urinary oxalate in obese people prone to kidney stones. It includes phases of low-oxalate diets and oral loads of oxalate/sucralose before and after weight loss.

What are the potential side effects?

Potential side effects may include digestive discomfort due to diet changes, possible nutritional deficiencies from a very low-calorie diet (VLCD), and reactions to oral loads like bloating or gastrointestinal distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My most recent kidney stone was mostly calcium oxalate.

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My kidney function tests are within the normal range for my gender.

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My blood pressure is controlled and below 160/90 mmHg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled high blood pressure or recent serious heart issues.

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I do not have cirrhosis, pancreatic/biliary disorders, porphyria, or gout.

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I do not have nephrotic syndrome, neurogenic bladder, or urinary diversion.

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I have a stomach or intestine condition or had surgery affecting oxalate in my body.

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I have a condition that causes high oxalate levels in my urine.

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I have type 2 diabetes or my A1c level is 6.5% or higher.

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My kidney function is reduced, with an eGFR below 60.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of 24 hour urinary oxalate excretion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Controlled Diet and Weight Loss ProgramExperimental Treatment6 Interventions

Subjects will consume a low oxalate diet with blood and urine collections to establish baseline levels before undergoing a weight loss program with Optifast VLCD products. After completing the weight loss program, subjects will once again consume a low oxalate diet with blood and urine collections to observe any changes that may have occurred due to the weight loss.

0 / 10Eligibility criteria met