Gut Microbiome and Sex as Risk Factors for Kidney Stones After Bariatric Surgery

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04590690
Status
Recruiting
Apply to this trial

Conditions

  • Bariatric Surgery Candidate

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Special diet — OTHER
    The research clinic will provide subjects with a special diet for six days. After six days of isocaloric sodium, calcium and fluid intake, the study team will analyze three sequential 24-hour urine compositions including supersaturation of calcium oxalate, calcium, and urine volume, as well as stool collections. We will also evaluate components of 24-hour urine composition, specifically supersaturation, and the microbial contributions to urinary composition in 72-hour stool samples simultaneously collected using shot-gun metagenomic sequencing in men and women 1 year after surgery.

Study Details

This is a single-center study that aims to better understand how diet and sex affect the risk of kidney stones in people who have had gastric bypass surgery. Subjects will be asked to follow a special (clinic-provided) diet for six days and come to a research clinic for 3 study visits.

Key Dates

Start date
Nov 1, 2020
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Roux-en-y gastric bypass subjects
    Inclusion Criteria: Age 18-70. Participants pre-Roux-en-y gastric bypass (RYGB) who are approved and planned for Roux-en-y gastric bypass surgery in the Bariatric Surgery Center at the UCM. Exclusion Criteria: Patients with primary kidney diseases, kidney stone disease, or kidney impairment (eGFR \< 90). Patients with known bladder voiding problems. Participants will complete a diet record and a 24-hour urine collection both before and after surgery. Participants will consume a 3 day fixed diet and present to the clinical research center for timed blood and urine draws. They will do this before and twice after (1 month and 1 year) surgery.
  • Experimental: Sleeve gastrectomy subjects
    Inclusion Criteria: Age 18-70. Participants pre-sleeve gastrectomy who are approved and sleeve gastrectomy in the Bariatric Surgery Center at the UCM. Exclusion Criteria: Patients with primary kidney diseases, kidney stone disease, or kidney impairment (eGFR \< 90). Patients with known bladder voiding problems. Participants will complete a diet record and a 24-hour urine collection both before and after surgery. Participants will consume a 3 day fixed diet and present to the clinical research center for timed blood and urine draws. They will do this before and twice after (1 month and 1 year) surgery.

Primary Outcome Measure

Change in urine calcium oxalate supersaturation over time [ Time Frame: Multiple times over approximately 13 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Megan Prochaska, MD
[email protected]
773-702-1000

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By research site
University of Chicago Medical Center· Chicago, IL

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