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Special Diet for Kidney Stones Post-Bariatric Surgery

Q: Can you confirm if this research effort is currently in the process of enrolling participants?

It has been confirmed on clinicaltrials.gov that this medical experiment is looking for participants. The trial was first listed on November 1st 2020 and the most recent edit happened on August 11th 2022.

Q: What criteria must a patient meet to be eligible for this experiment?

People between the ages of 18 and 130 who have been diagnosed with nephrolithiasis are eligible for this medical trial. This project is intending to enrol a total of 28 individuals.

Q: What is the limit for participants in this scientific research?

Affirmative. According to information on clinicaltrials.gov, this medical study is recruiting participants as of now. This trial was initially unveiled on November 1st 2020 and the latest update came through on August 11th 2022 - with 28 patients needed from a single site.

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

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

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in urine calcium oxalate supersaturation over time

Secondary outcome measures

Calcium

Oxalate

Urine citrate

+1 more

Other outcome measures

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

Association of first and measures with glucagon (physiologic parameter)

Insulin

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,763 Total Patients Enrolled

1 Trials studying Bariatric Surgery Candidates

30 Patients Enrolled for Bariatric Surgery Candidates

Prochaska Megan, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Special diet Clinical Trial Eligibility Overview. Trial Name: NCT04590690 — N/A

Bariatric Surgery Candidates Research Study Groups: Roux-en-y gastric bypass subjects, Sleeve gastrectomy subjects

Bariatric Surgery Candidates Clinical Trial 2023: Special diet Highlights & Side Effects. Trial Name: NCT04590690 — N/A

Special diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04590690 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you confirm if this research effort is currently in the process of enrolling participants?

"It has been confirmed on clinicaltrials.gov that this medical experiment is looking for participants. The trial was first listed on November 1st 2020 and the most recent edit happened on August 11th 2022."

Answered by AI

What criteria must a patient meet to be eligible for this experiment?

"People between the ages of 18 and 130 who have been diagnosed with nephrolithiasis are eligible for this medical trial. This project is intending to enrol a total of 28 individuals."

Answered by AI

What is the limit for participants in this scientific research?

"Affirmative. According to information on clinicaltrials.gov, this medical study is recruiting participants as of now. This trial was initially unveiled on November 1st 2020 and the latest update came through on August 11th 2022 - with 28 patients needed from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Gut Microbiome and Sex as Risk Factors for Kidney Stones After Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04590690.

All > Kidney Stone > Microbiome