Kidney Stone Inflammation

NCT06436235 | Recruiting

• 1 other identifier: IRB24-0024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  Levels of visceral fat as measured by dual x-ray absorptiometry (DEXA).

  1 week total, one half day in the CRC

• Difference in inflammatory markers between participants who form kidney stones and controls

  Markers of systemic inflammation, including high-sensitivity CRP, interleukin-6, MMP-7, MMP-9, TNF-alpha, and endotrophin.

  1 week total, one half day in the CRC

Secondary Outcomes (5)

• Correlation between visceral fat and inflammatory markers

  1 week total, one half day in the CRC

• Differences in urine composition

  1 week total, one half day in the CRC

• Differences in visceral fat levels

  1 week total, one half day in the CRC

• Differences in insulin resistance between kidney stone patients and controls

  Time Frame: 1 week total, one half day in the CRC

• Differences in markers of systemic inflammation between kidney stone patients and controls

  Time Frame: 1 week total, one half day in the CRC

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney Stone Former Group: Age 18-70 years old History of at least one calcium-based kidney stone Control Group: Age 18-70 years old No personal history of kidney stones No 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 diuretic use Medications that cannot be stopped that may affect urine composition Previous bariatric surgery or ileostomy Primary hyperparathyroidism and elevated serum calcium

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Any urine or serum/plasma that is not utilized for the specified measurements in this study will be frozen at -80°C and retained as biospecimens.

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Prochaska, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Prochaska, MD

CONTACT

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

Elaine Worcester, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 31, 2024
• Study Start: June 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-09

Locations

US (1)