| NCT ID | NCT06436235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Kidney Stone |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-30 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-06-30 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational study aims to look at the connections between kidney stones, insulin resistance, and inflammation. The researchers hypothesize that people who form calcium kidney stones and have insulin resistance may have higher levels of inflammation because they have more visceral fat (fat around the abdominal organs). The study will recruit 20 people who have had calcium kidney stones but don't have diabetes, and 20 healthy people who haven't had kidney stones. All the participants will come to the research center at the University of Chicago Medicine. Participants will have a dual-energy X-ray absorptiometry (DEXA) scan to measure their visceral fat, and give blood and urine samples. The blood will be tested for insulin resistance, inflammatory markers, and other metabolic factors. The urine will be analyzed for substances that increase kidney stone risk. The main goal is to see if the kidney stone formers with insulin resistance have more visceral fat compared to those without insulin resistance and the healthy participants. The researchers will also compare inflammatory marker levels between groups, and look at how visceral fat, inflammatory markers, insulin resistance, and urine stone risk factors are related. The findings may help explain how kidney stones are connected to metabolic conditions like diabetes and cardiovascular disease. Researchers hope this information will help identify stone formers at risk early and develop preventive treatments in the future.
Eligibility Criteria
Inclusion Criteria: * Stone formers: * Age 18-70 * History of at least one calcium-based kidney stone * Healthy Controls: * Age 18-70 * No history of kidney stone or family history of kidney stones Exclusion Criteria (for both groups): * History of primarily uric acid * Cysteine, or struvite stones * History of diabetes or impaired glucose tolerance * Previous thiazide use * Anyone on a medication that cannot be stopped that may affect urine composition * Previous bariatric surgery or ileostomy * Primary hyperparathyroidism and elevated serum calcium.
Contact & Investigator
Megan Prochaska, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06436235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06436235 currently recruiting?
Yes, NCT06436235 is actively recruiting participants. Contact the research team at mprocha2@medicine.bsd.uchicago.edu for enrollment information.
Where is the NCT06436235 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06436235 clinical trial?
NCT06436235 is sponsored by University of Chicago. The principal investigator is Megan Prochaska, MD at University of Chicago. The trial plans to enroll 40 participants.
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