Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID06436235

Inflammation and Insulin Resistance in Kidney Stone Patients

Led by University of Chicago · Updated on 2025-10-14

40

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring the relationships among kidney stones, insulin resistance, and inflammation in people who have had calcium kidney stones but do not have diabetes, compared to healthy individuals without kidney stones. The study aims to determine whether those with kidney stones and insulin resistance have higher levels of visceral fat and inflammation. Understanding these connections may help identify individuals at risk for metabolic conditions like diabetes and heart disease. Participants include 20 people with a history of calcium kidney stones and 20 healthy controls. Before the study visit, participants stop certain supplements and medications and complete a urine collection and dietary questionnaire at home. On the study day, participants visit the research center in a fasting state for measurements including height, weight, waist and neck circumference, blood pressure, and a DEXA scan to assess visceral fat and bone density. They provide blood and urine samples throughout the day for analysis of stone risk factors, insulin resistance, and inflammatory markers. During the visit, clinical history related to kidney stones is recorded. Urine and blood samples are analyzed for various chemicals and markers related to kidney stone risk, inflammation, and metabolism, with some samples stored for future research. The main outcomes include differences in visceral fat and inflammation between groups, with additional measures assessing the relationships among fat, inflammation, insulin resistance, and urine composition. The total participation time is about one week including preparation and the half-day research center visit.

CONDITIONS

Brief Title

Kidney Stone Inflammation

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years
  • For stone formers: history of at least one calcium-based kidney stone
  • For healthy controls: no history of kidney stones or family history of kidney stones
Not Eligible

You will not qualify if you...

  • History of primarily uric acid, cysteine, or struvite stones
  • History of diabetes or impaired glucose tolerance
  • Previous thiazide use
  • Use of medications that cannot be stopped and may affect urine composition
  • Previous bariatric surgery or ileostomy
  • Primary hyperparathyroidism with elevated serum calcium

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Observational Assessments

Duration - 1 week total, including one half day in the Clinical Research Center

Participants complete pre-study procedures including stopping certain supplements and diuretics for one week, collecting a 24-hour urine sample, and completing a food questionnaire at home. On the study day, participants visit the Clinical Research Center in a fasted state to provide urine and blood samples, undergo blood pressure measurements, anthropometric measurements, a DEXA scan, and a clinical history review.

1 visit (half day, in-person) plus home collection of urine and questionnaire

Trial Site Locations

Total: 1 location

1

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

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Research Team

M

Megan Prochaska, MD

E

Elaine Worcester, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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