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Special Diet for Kidney Stones Post-Bariatric Surgery

N/A

Recruiting

Led By Prochaska Megan, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants pre-bariatric surgery who are approved and planned for surgery in the Bariatric Surgery Center at University of Chicago Medicine.

Be older than 18 years old

Must not have

Patients with primary renal diseases or renal impairment (eGFR < 90)

Patients with known bladder voiding problems

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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])

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating how diet and sex affect the risk of kidney stones in people who have had gastric bypass surgery.

Who is the study for?

This trial is for individuals approved for bariatric surgery at the University of Chicago Medicine, who have no personal or family history of kidney stones. It's not open to those with vitamin D deficiency (levels below 25ng/mL), primary renal diseases, impaired kidney function (eGFR < 90), or known bladder voiding issues.

What is being tested?

The study investigates how a special diet affects the risk of developing kidney stones after gastric bypass surgery. Participants will follow this clinic-provided diet for six days and attend three research clinic visits.

What are the potential side effects?

Since this trial involves following a special diet rather than medication, side effects may be minimal but could include digestive changes depending on individual tolerance to the dietary regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am approved for and scheduled to have bariatric surgery at the University of Chicago Medicine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is impaired.

Select...

I have issues emptying my bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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])

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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])

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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]) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in urine calcium oxalate supersaturation over time

Secondary study objectives

Calcium

Oxalate

Urine citrate

+1 more

Other study objectives

Association of first and measures with GLP-1 (physiologic parameter)

Association of first and measures with glucagon (physiologic parameter)

Insulin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sleeve gastrectomy subjectsExperimental Treatment1 Intervention

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.

Group II: Roux-en-y gastric bypass subjectsExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met