Gut Microbiome and Sex as Risk Factors for Kidney Stones After Bariatric Surgery
1 other identifier
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 11, 2026
May 1, 2026
6.3 years
September 25, 2020
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in urine calcium oxalate supersaturation over time
Calculated using EQUIL2 from the measured urine calcium, citrate, oxalate, and volume that are directly measured in the urine
Multiple times over approximately 13 months
Secondary Outcomes (4)
Urine citrate
Multiple times over approximately 13 months (a. at the start [approximately 1 month prior to surgery] b. about 2 months in [approximately 1 month after surgery] and c. at the end [approximately 13 months from start])
Calcium
Multiple times over approximately 13 months (a. at the start [approximately 1 month prior to surgery] b. about 2 months in [approximately 1 month after surgery] and c. at the end [approximately 13 months from start])
Oxalate
Multiple times over approximately 13 months (a. at the start [approximately 1 month prior to surgery] b. about 2 months in [approximately 1 month after surgery] and c. at the end [approximately 13 months from start])
Volume
Multiple times over approximately 13 months (a. at the start [approximately 1 month prior to surgery] b. about 2 months in [approximately 1 month after surgery] and c. at the end [approximately 13 months from start])
Other Outcomes (3)
Association of first and secondary outcomes measures with serum insulin (physiologic parameter)
1 day (Drawn once)
Association of first and secondary outcomes measures with GLP-1 (physiologic parameter)
1 day (Drawn once)
Association of first and secondary outcomes measures with glucagon (physiologic parameter)
1 day (Drawn once)
Study Arms (2)
Roux-en-y gastric bypass subjects
EXPERIMENTALInclusion 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.
Sleeve gastrectomy subjects
EXPERIMENTALInclusion 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants without history of stone disease, family history of stone disease
- Participants pre-bariatric surgery who are approved and planned for surgery in the Bariatric Surgery Center at University of Chicago Medicine.
You may not qualify if:
- Patients with primary renal diseases or renal impairment (eGFR \< 90)
- Patients with known bladder voiding problems
- Patients with 25-vitamine D deficiency, as defined by level \< 25ng/mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prochaska Megan, MD
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
October 19, 2020
Study Start
November 1, 2020
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 11, 2026
Record last verified: 2026-05