Kidney Stone Inflammation

NCT ID: NCT06436235

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-08-01

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.

Detailed Description

Participants will be recruited from the University of Chicago Medicine Kidney Stone Clinic (stone formers) and research participant registries (controls). After providing informed consent, participants will complete the following procedures:

Pre-Study:

1. One week prior, participants will discontinue vitamin C, multivitamins, calcium supplements, and diuretics.

2. One day prior, participants will complete a 24-hour urine collection and food frequency questionnaire at home.

Study Visit:

2. Participants will be admitted to the University of Chicago's Clinical Research Center (CRC) in a fasted state.

3. Three timed (45 minute) urine and blood specimen collections will occur.

4. Three seated blood pressure measurements will be taken.

5. Anthropometric measurements including height, weight, waist and neck circumference will be obtained.

6. A dual-energy X-ray absorptiometry (DEXA) scan will be performed to measure visceral fat content and bone density.

7. A brief clinical history will be obtained, including data on kidney stone episodes, procedures, and current stone burden.

8. Participants will remain fasted until all biological samples have been collected. Water intake will be allowed ad libitum.

Sample Analysis:

Urine:

1.24-hour and timed urine samples will be analyzed for kidney stone risk chemistries including volume, pH, solutes (calcium, oxalate, uric acid, citrate, etc).

2. Urine supersaturations for calcium oxalate, calcium phosphate, and uric acid will be calculated using EQUIL2 software.

3. Urine albumin and creatinine will be measured.

4. Remaining urine will be stored at -80°C for potential future assays.

Blood:

1. Serum glucose will be measured at the CRC laboratory.

2. Serum insulin, C-peptide, glucagon, GLP-1, and inflammatory markers (high-sensitivity CRP [C-reactive protein], IL-6, MMPs [matrix metalloproteinases], TNF-alpha, endotrophin) will be measured at the Diabetes Research and Training Center at the University of Chicago.

3. Other serum chemistries (electrolytes, calcium, creatinine, HbA1c, lipids) will be measured at the clinical laboratory.

4. Remaining serum will be stored at -80°C.

Conditions

Kidney Stone; Stone, Kidney

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Prochaska, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Megan Prochaska, MD

Role: CONTACT

mprocha2@medicine.bsd.uchicago.edu

773-702-1000 ext. 45488

Elaine Worcester, MD

Role: CONTACT

eworcest@medicine.bsd.uchicago.edu

773-702-3630

Facility Contacts

Megan Prochaska, MD

Role: primary

mprocha2@medicine.bsd.uchicago.edu

773-702-1000 ext. 45488

Other Identifiers

IRB24-0024

Identifier Type: -

Identifier Source: org_study_id