Clinical trial

Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone Formers

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04633811

Active, not recruitingNot applicableInterventional

What this study is about

This protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis and dietary oxalate absorption to the urinary oxalate pool in obese calcium oxalate stone formers.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age19 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionKidney Stone

Full registry criteria

Inclusion Criteria: * First time or recurrent calcium oxalate stone formers defined as composition of most recent stone \>50% calcium oxalate without uric acid component * Last stone passage or removal greater than 3 months prior to screening * Body Mass Index (BMI) \>35 kg/m2 * Able to provide consent * Hemoglobin A1C \<6.5% * Normal fasting blood CMP: Normal serum Na, K, Cl, CO2, Calcium, Albumin, AST, ALT \<2 times upper limit of normal, Glucose \<126 mg/dl, eGFR \>60 ml/min/1.73 m2. * 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) * Willing to ingest menus prepared at the University of Alabama and University of Texas Southwestern Clinical Research Units * Willing to consume the Optifast VLCD diet * Willing to ingest menus prepared in Metabolic kitchen. No food allergies or intolerance to any of the foods in study menus. Substitutions for lactose intolerance will be made. * Willing to avoid vigorous exercise during eucaloric, low-oxalate dietary phase * Willing to stop use of weight-loss medications * Willing to stop for 14 days before and during study: medications for stone prevention including diuretics, potassium citrate, allopurinol, febuxostat, and calcium, nutritional, or herbal supplements * Those with controlled hypertension (systolic blood pressure \<160 mmHg, diastolic \<90 mmHg) will be included. * Those without severe dyslipidemia (LDL \<200 mg/dL, HDL \>30 mg/dL, and triglycerides \<250 mg/dL) will be included. Treated and controlled dyslipidemia is accepted * Smoking/chewing tobacco/vaping will be allowed Exclusion Criteria: * Renal colic or past stone surgery in the past 3 months * Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73m2 * History of type 2 diabetes or screening hgb A1c greater than or equal to 6.5% * Alcohol or drug abuse. Alcohol consumption \>12 units per week and/or unwillingness to abstain from alcohol consumption 2 days before and during the study. * Mental/medical condition likely to impede study completion * Current/planned pregnancy or breastfeeding in coming 6 months, unwillingness to use effective method of birth control during the study for individuals of childbearing potential. * Planned vacation in coming 4 months * Febrile illness including flu/common cold/COVID-19 within 21 days of study start * Primary or enteric hyperoxaluria * Gastrointestinal disorder or surgery that impacts oxalate transport * Cirrhosis, pancreatic or biliary disorder, porphyria, gout * Malignancy treated within the past 12 months * Nephrotic syndrome, neurogenic bladder, urinary diversion * History of primary hyperparathyroidism, cystinuria, renal tubular acidosis, sarcoidosis, cystic fibrosis * Uncontrolled hypertension, myocardial infarction in past 6 months, unstable angina, congestive heart failure * Medications: Topiramate, acetazolamide, zonisamide, diuretics, SGLT2-inhibitors, immunosuppressants

Treatments and study arms

Low Oxalate Diet before Weight Loss

Dietary Supplement

Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 6 days. 2 x 24 hour urines will be collected on days 3 and 4.

Oral load of oxalate and sucralose before Weight Loss

Dietary Supplement

Subjects will ingest 100mg carbon-13 oxalate, and 1 gram of sucralose on day 5 of the 6-day low oxalate diet phase. Following the oral load, blood and urine will be collected every 30 minutes and hourly, respectively

Optifast VLCD Program

Dietary Supplement

Subjects will go on a 10-week Intestive level Optifast VLCD weight loss program

Optifast VLCD Transition Phase

Dietary Supplement

After completion of the 10-week Optifast VLCD Program, subjects will be weaned off the Optifast products for 4 weeks.

Low Oxalate Diet after Weight Loss

Dietary Supplement

Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 11 days and collect 2 x 24 hour urines on days 8 and 9

Oral load of oxalate and sucralose after Weight Loss

Dietary Supplement

Subjects will ingest 100mg carbon-13 oxalate, and 1 gram of sucralose on day 10 of the 11-day low oxalate diet phase. Following the oral load, blood and urine will be collected every 30 minutes and hourly, respectively

Primary outcomes

Measurement of 24 hour urinary oxalate excretion4 days

Subjects will ingest a controlled diet low in oxalate and collect 2 x 24-hour urines before and after the Optifast VLCD Program. The utilization of a low oxalate diet allows assessment of the change in contribution of endogenous oxalate synthesis to the urinary oxalate pool.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States