Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06436235

Conditions

Kidney Stone

Stone, Kidney

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Kidney Stone

Stone, Kidney

Study ID

NCT06436235

Start date

Jun 30, 2024

Status verified date

Jul, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Kidney stone formers

The study team plans to enroll 20 non-diabetic participants with a history of at least one calcium-based kidney stone. Activities are the same for both cohorts, as follows:

  • Before clinic visit, participants will halt specific supplements and diuretics for a week.
  • At home, they complete a dietary questionnaire and collect 24-hour urine.
  • On the 7th day, they visit University of Chicago CRC. There, investigators will take measurements (height, weight) and DEXA scan, alongside kidney stone history review.
  • Throughout the day, participants provide urine and blood samples, undergo blood pressure checks, and fast until sample collection.
  • Samples undergo testing for kidney stone, inflammation, and diabetes risk factors and are stored for future research.

Control cohort

The study team plans to enroll 20 healthy control participants with no history of kidney stones or family history of kidney stones. Activities are the same for both cohorts, as follows:

  • Before clinic visit, participants will halt specific supplements and diuretics for a week.
  • At home, they complete a dietary questionnaire and collect 24-hour urine.
  • On the 7th day, they visit University of Chicago CRC. There, investigators will take measurements (height, weight) and DEXA scan, alongside kidney stone history review.
  • Throughout the day, participants provide urine and blood samples, undergo blood pressure checks, and fast until sample collection.
  • Samples undergo testing for kidney stone, inflammation, and diabetes risk factors and are stored for future research.

Primary outcome measure

  • Difference in visceral fat content in participants who form kidney stones with insulin resistance compared to participants who form kidney stones without insulin resistance and controls [ Time Frame: 1 week total, one half day in the CRC ]
  • Difference in inflammatory markers between participants who form kidney stones and controls [ Time Frame: 1 week total, one half day in the CRC ]

Central Contacts and Locations

Central contacts

Megan Prochaska, MD

773-702-1000mprocha2@medicine.bsd.uchicago.edu

Elaine Worcester, MD

773-702-3630eworcest@medicine.bsd.uchicago.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Megan Prochaska, MD

773-702-1000mprocha2@medicine.bsd.uchicago.edu

Principal Investigator:

Megan Prochaska, MD

More Information

Sponsor

University of Chicago

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-07-08.