Kidney Stone Inflammation

Inflammation and Insulin Resistance in Kidney Stone Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stone, Kidney; Kidney Stone

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Megan Prochaska, MD; Phone Number: 45488 773-702-1000; Email: mprocha2@medicine.bsd.uchicago.edu
• Study Contact Backup: Name: Elaine Worcester, MD; Phone Number: 773-702-3630; Email: eworcest@medicine.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
      • Contact: Megan Prochaska, MD; Phone Number: 45488 773-702-1000; Email: mprocha2@medicine.bsd.uchicago.edu
      • Principal Investigator: Megan Prochaska, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between visceral fat and inflammatory markers	Correlation between visceral fat levels (measured by dual x-ray absorptiometry [DEXA]) and the following markers of systemic inflammation: High-sensitivity C-reactive protein (CRP); Interleukin-6 (IL-6); Matrix metalloproteinase-7 (MMP-7); Matrix metalloproteinase-9 (MMP-9); Tumor necrosis factor-alpha (TNF-alpha); Endotrophin	1 week total, one half day in the CRC
Differences in urine composition	Differences in urine composition based on: Levels of insulin resistance; Visceral fat content (measured by DEXA); Levels of inflammatory markers (CRP, IL-6, MMP-7, MMP-9, TNF-alpha, endotrophin)	1 week total, one half day in the CRC
Differences in visceral fat levels	Differences in visceral fat levels (measured by DEXA) between kidney stone patients and controls	1 week total, one half day in the CRC
Differences in insulin resistance between kidney stone patients and controls	Differences in insulin resistance between kidney stone patients and controls, measured by: Fasting blood glucose; Fasting insulin; Homeostatic model assessment of insulin resistance (HOMA-IR)	Time Frame: 1 week total, one half day in the CRC
Differences in markers of systemic inflammation between kidney stone patients and controls	Differences in markers of systemic inflammation between kidney stone patients and controls, including: High-sensitivity C-reactive protein (CRP); Interleukin-6 (IL-6); Matrix metalloproteinase-7 (MMP-7); Matrix metalloproteinase-9 (MMP-9); Tumor necrosis factor-alpha (TNF-alpha); Endotrophin	Time Frame: 1 week total, one half day in the CRC

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Megan Prochaska, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi
• Other Study ID Numbers: IRB24-0024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No