Gut Microbiome and Sex as Risk Factors for Kidney Stones After Bariatric Surgery
ConditionBariatric Surgery Candidate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-130
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Special diet
Other interventionThe 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Roux-en-y gastric bypass subjectsExperimental treatment 1 intervention
Group B: Sleeve gastrectomy subjectsExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Multiple times over approximately 13 monthsSecondary outcomes
1
Urine citrate
Measured directly in the urine
Time frame
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])2
Calcium
Measured directly in the urine
Time frame
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])3
Oxalate
Measured directly in the urine
Time frame
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])4
Volume
Measured directly in the urine
Time frame
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
1
Association of first and secondary outcomes measures with serum insulin (physiologic parameter)
Measured directly in the urine and blood
Time frame
1 day (Drawn once)2
Association of first and secondary outcomes measures with GLP-1 (physiologic parameter)
Measured directly in the urine and blood
Time frame
1 day (Drawn once)3
Association of first and secondary outcomes measures with glucagon (physiologic parameter)
Measured directly in the urine and blood
Time frame
1 day (Drawn once)Sponsors and contacts
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Source ClinicalTrials.gov