Kidney Stone Inflammation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-70
History of at least one calcium-based kidney stone
Age 18-70
No history of kidney stone or family history of kidney stones
Disqualifiers
History of primarily uric acid
Cysteine, or struvite stones
History of diabetes or impaired glucose tolerance
Previous thiazide use
Trial 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Kidney stone formers
Group B: Control cohort
Trial outcomes
Primary outcomes
1
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).
Time frame
1 week total, one half day in the CRC2
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.
Time frame
1 week total, one half day in the CRCSecondary outcomes
1
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
Time frame
1 week total, one half day in the CRC2
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)
Time frame
1 week total, one half day in the CRC3
Differences in visceral fat levels
Differences in visceral fat levels (measured by DEXA) between kidney stone patients and controls
Time frame
1 week total, one half day in the CRC4
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
Time Frame: 1 week total, one half day in the CRCSponsors and contacts
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Source ClinicalTrials.gov