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Dietary Supplement
Diet Impact on Kidney Stones in Obese Individuals
N/A
Waitlist Available
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
Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study
First time or recurrent calcium oxalate stone former
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 5
Awards & highlights
Study Summary
This trial will help researchers learn more about how different aspects of diet contribute to kidney stones in people of normal weight and in obese people.
Who is the study for?
This trial is for adults with normal (BMI ≥ 18.5 to < 25) or obese (BMI ≥ 30 to ≤ 45) who form calcium oxalate kidney stones, can consent, and follow a controlled diet without vigorous exercise. Excluded are those with diabetes, abnormal blood tests, certain kidney diseases, gastrointestinal disorders affecting oxalate transport, recent cancer treatment, pregnancy or breastfeeding women not using birth control.Check my eligibility
What is being tested?
The study investigates how obesity affects the body's processing of oxalate in people prone to calcium oxalate kidney stones. Participants will follow a controlled diet and ingest Carbon-13 Oxalate and Sucralose to track their metabolism and urinary excretion patterns.See study design
What are the potential side effects?
While the trial involves dietary changes rather than medication, potential side effects may include digestive discomfort due to new foods or supplements ingested during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to stop my kidney stone prevention meds for the study duration.
Select...
I have had kidney stones made of calcium oxalate before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary Oxalate Excretion
Trial Design
1Treatment groups
Experimental Treatment
Group I: Controlled Dietary StudyExperimental Treatment2 Interventions
Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,283,073 Total Patients Enrolled
14 Trials studying Kidney Stones
813 Patients Enrolled for Kidney Stones
Dean Assimos, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
80 Total Patients Enrolled
2 Trials studying Kidney Stones
80 Patients Enrolled for Kidney Stones
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with primary hyperparathyroidism.I have high oxalate levels in my urine due to intestinal issues.I am willing to stop my kidney stone prevention meds for the study duration.Your fasting blood test shows abnormal results for your body's chemical levels.My kidney function tests are within the normal range for my gender and weight.I have had kidney stones made of calcium oxalate before.I have a condition where my bladder doesn't empty properly due to nerve issues.You are not underweight or extremely overweight.I have not taken antibiotics in the last 6 months.Your HbA1c level is 6.5% or higher.I have been diagnosed with nephrotic syndrome.I have gout.My kidney function is reduced.I have been diagnosed with primary hyperoxaluria.I am currently taking medication that suppresses my immune system.I cannot use birth control during the study.I have not had diarrhea or unusual bowel movements in the last 14 days.I am willing to stop taking supplements for 14 days before and during the study.I cannot or do not want to have an MRI.I have diabetes.I have been diagnosed with renal tubular acidosis.I have a stomach or intestine condition that affects oxalate processing.I have been diagnosed with sarcoidosis.I have had weight loss surgery.I have long-term diarrhea.You have a urinary diversion.I have not had cancer or cancer treatment in the last year.I have a liver condition.I have not had the flu, a cold, or a fever in the last 14 days.You have a history of forming uric acid stones.Your most recent kidney stone is made up of more than half calcium oxalate and does not contain uric acid.I have been diagnosed with cystinuria.My high blood pressure is not under control.Your blood test results for fasting Comprehensive Metabolic Panel are normal.Your hemoglobin A1c level is less than 6.5%.I have cystic fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Controlled Dietary Study
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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