Health TrialsbyHealthPanel

GI Oxalate Absorption

ConditionsBariatric Surgery CandidateKidney Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Subjects who will follow low-oxalate diet followed by visit to research clinicOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

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)

Time frame
6 days
2

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

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.

Time frame
6 days
3

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

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.

Time frame
6 days
4

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

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.

Time frame
6 days

Secondary outcomes

1

Compare change in urine oxalate levels from baseline to post-low oxalate diet between the three groups: lean kidney stone patients, obese kidney stone patients, and post- Roux-en-Y gastric bypass kidney stone patients

1\. 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).

Time frame
6 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

University of Alabama at Birmingham

Collaborator

Source ClinicalTrials.gov
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