RecruitingNot ApplicableNCT05356000

GI Oxalate Absorption

Determine the Contribution of Paracellular GI Oxalate Absorption in Obese and Roux-en-Y Gastric Bypass Kidney Stone Patients


Sponsor

University of Chicago

Enrollment

30 participants

Start Date

Jan 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria13

  • 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 Criteria10

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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.


Locations(1)

University of Chicago Medical Center

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05356000


Related Trials