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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
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 belowSelect...
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:Select...
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
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
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.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
1,072 Previous Clinical Trials
1,056,222 Total Patients Enrolled
5 Trials studying Kidney Stones
752 Patients Enrolled for Kidney Stones
University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,938 Total Patients Enrolled
13 Trials studying Kidney Stones
735 Patients Enrolled for Kidney Stones
Dean Assimos, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
62 Total Patients Enrolled
2 Trials studying Kidney Stones
62 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My last kidney stone was passed or removed over 3 months ago.I do not have uncontrolled high blood pressure or recent serious heart issues.I have a history of conditions like hyperparathyroidism or cystic fibrosis.I do not have cirrhosis, pancreatic/biliary disorders, porphyria, or gout.I have no vacations planned in the next 4 months.I have been treated for cancer within the last year.I do not have nephrotic syndrome, neurogenic bladder, or urinary diversion.Your hemoglobin A1C level is lower than 6.5%.You drink more than 12 alcoholic drinks a week and are not willing to stop drinking for 2 days before and during the study.I have a stomach or intestine condition or had surgery affecting oxalate in my body.I have not had a fever or flu-like symptoms, including COVID-19, in the last 21 days.I have a condition that causes high oxalate levels in my urine.My most recent kidney stone was mostly calcium oxalate.You have a BMI higher than 35, which means you are severely overweight.Your blood test results for sodium, potassium, chloride, carbon dioxide, calcium, albumin, AST, ALT, and glucose are within normal range, and your kidney function is good.My kidney function tests are within the normal range for my gender.My blood pressure is controlled and below 160/90 mmHg.I am willing to stop taking stone prevention meds and supplements for 14 days before and during the study.My cholesterol and triglyceride levels are within safe ranges.It's okay if you smoke, chew tobacco, or vape.I am not taking topiramate, acetazolamide, zonisamide, diuretics, SGLT2-inhibitors, or immunosuppressants.I have type 2 diabetes or my A1c level is 6.5% or higher.My kidney function is reduced, with an eGFR below 60.I have had kidney stone pain or surgery in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Controlled Diet and Weight Loss Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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