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

Kidney Stone Clinical Trial

Official title: Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

Obese adults (≥19 and ≤ 65 years) with a history of calcium oxalate kidney stone disease will be recruited at both University of Alabama at Birmingham (UAB) and University of Texas South Western (UTSW). Following consent, subjects will complete a screening phase, which includes (1) a meeting with a dietitian to ensure willingness to consume controlled ultra-low oxalate diets and determine anthropometric measurements and blood pressure, (2) collection of fasted blood and 2 x 24-hour urine specimens on self-choice diets to determine general health status and urinary chemistries, respectively, (3) completion of a 7-day run-in diet that includes the use of one serving of an Optifast meal daily to assess tolerance to Optifast VLCD® products. Participants will then consume an eucaloric, ultra-low oxalate controlled diet for 6 days. The controlled dietary phase involves 2 days of dietary equilibration, followed by 2 x 24-hour urine collections, and on the 5th day a dietary oxalate/sucralose oral load. Following the dietary oxalate/sucralose oral load, subjects will have blood collected every 30 minutes and collect 1-hour urines. Participants will then go on an intensive 14-week Optifast VLCD® Program to induce weight loss. At the end of this Optifast VLCD® Program participants will again perform the low oxalate controlled diet and dietary/sucralose oral load study. A total of 40 adult obese calcium oxalate kidney stone formers (20 male and 20 female) will be enrolled (20 at UAB and 20 at UTSW). ;

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Weight Loss

• NCT number: NCT04633811
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Jane Vines, MPH
• Phone: 205-224-7324
• Email: kidneystoneresearch@uabmc.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2021
• Completion date: December 31, 2025