TrialGlobe

Clinical trial

GI Oxalate Absorption

Recruiting now · Not applicable · 1 countries · Registry ID NCT05356000

Recruiting nowNot applicableInterventional

What this study is about

This study aims to learn more about how oxalate, a compound found in many foods, may affect a person's chances of forming kidney stones. Active participation in this study will last for around one week. For the first two days, subjects will be asked to eat a special diet at home. From Days 3-5, they will eat special meals delivered to their home from a research clinic at the University of Chicago. They will also collect 24-hour urine samples at home on Days 4 and 5. On Day 6, they will come in to the research clinic at the University of Chicago in Hyde Park, where they will spend most of the day. They will receive a special liquid that contains oxalate, and we will have them eat a specially prepared breakfast that is low in oxalate and citrate.

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

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionBariatric Surgery Candidate, Kidney Stone

Full registry criteria

Inclusion Criteria: Post-Roux-en-Y gastric bypass stone formers: * Age 18-70 * Previous history of Roux-en-Y gastric bypass * History of at least one calcium-based kidney stone after surgery * Pre-protocol urine oxalate above the lab normal range (50mg/day) Obese stone formers: * Age 18-70 * Body mass index (BMI) \>=30kg/m2 * History of at least one calcium-based kidney stone * Pre-protocol urine oxalate above the lab normal range (50mg/day) Non-obese stone formers: * Age 18-70, BMI between 18.5-29.9 kg/m2 * History of at least one calcium-based kidney stone Exclusion Criteria: Post-Roux-en-Y gastric bypass stone formers: * History of colon resection (partial or complete) * History of duodenal switch bowel surgery * History of ileal-jejunal bypass surgery * History of primarily uric acid, cysteine, or struvite stones Obese and non-obese stone formers: * History of bowel surgery * History of colon resection * History of inflammatory bowel disease (Crohn's disease, Ulcerative Colitis) * History of primarily uric acid, cysteine, or struvite stones

Treatments and study arms

Special low-oxalate diet followed by all-day visit to University of Chicago research clinic

Other

Active participation in this study will last for around one week. For the first two days, participants will be asked to eat a special diet at home. From Days 3-5, they will eat special meals that will be delivered to their home from a research clinic at the University of Chicago. They will also collect urine at home on Days 4 and 5. On Day 6, subjects will come in to the research clinic at the University of Chicago in Hyde Park, where they will spend most of the day. They will receive a special liquid that contains oxalate, and will receive a specially prepared breakfast that is low in oxalate and citrate. After this, we will collect their urine and blood throughout the day. We will draw blood 4 separate times.

Primary outcomes

Change in 24-hour urine oxalate from baseline to after 5 days on low oxalate diet (2 days on participant managed, 3 days on clinical research center prepared diet of 50mg/day)6 days

24-hour urine oxalate will be measured before and after participants follow a low oxalate diet for 5 total days (3 days will be clinical research center prepared food with known measured oxalate content of 50mg/day)

Percent absorption of 13C2-oxalate from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points6 days

Will be measured or calculated at time points 0, 2-hours, 4-hours, 6-hours and 24-hours after sodium 13C2-oxalate and sucralose consumption. We will compare change in urine total urine oxalate and 13C2-oxalate/total oxalate and sucralose each time period for all participants.

Change in urine 13C2-oxalate from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points6 days

Will be measured or calculated at time points 0, 2-hours, 4-hours, 6-hours and 24-hours after sodium 13C2-oxalate and sucralose consumption. We will compare change in urine total urine oxalate and 13C2-oxalate/total oxalate and sucralose each time period for all participants.

Percent absorption total urine oxalate from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points6 days

Will be measured or calculated at time points 0, 2-hours, 4-hours, 6-hours and 24-hours after sodium 13C2-oxalate and sucralose consumption. We will compare change in urine total urine oxalate and 13C2-oxalate/total oxalate and sucralose each time period for all participants.

Percent absorption of sucralose from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points6 days

Will be measured or calculated at time points 0, 2-hours, 4-hours, 6-hours and 24-hours after sodium 13C2-oxalate and sucralose consumption. We will compare change in urine total urine oxalate and 13C2-oxalate/total oxalate and sucralose each time period for all participants.

Change in urine sucralose from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points6 days

Will be measured or calculated at time points 0, 2-hours, 4-hours, 6-hours and 24-hours after sodium 13C2-oxalate and sucralose consumption. We will compare change in urine total urine oxalate and 13C2-oxalate/total oxalate and sucralose each time period for all participants.

Study locations

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University of Chicago Medical Center🇺🇸 Chicago, Illinois, United States
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Megan Prochaska, MDContact
Email · Call 773-702-1000
Megan Prochaska, MDPrincipal Investigator