Kidney StoneNCT06436235
Kidney Stone Inflammation
An observational study of Kidney Stone and Stone, Kidney, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Stone, Kidney
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2024to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Megan Prochaska, MD, 773-702-1000 ext. 45488, mprocha2@medicine.bsd.uchicago.edu
Megan Prochaska, MD
About this study
Official title: 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.
Read more
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.
Read the 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:
- One week prior, participants will discontinue vitamin C, multivitamins, calcium supplements, and diuretics.
- One day prior, participants will complete a 24-hour urine collection and food frequency questionnaire at home.
Study Visit:
- Participants will be admitted to the University of Chicago's Clinical Research Center (CRC) in a fasted state.
- Three timed (45 minute) urine and blood specimen collections will occur.
- Three seated blood pressure measurements will be taken.
- Anthropometric measurements including height, weight, waist and neck circumference will be obtained.
- A dual-energy X-ray absorptiometry (DEXA) scan will be performed to measure visceral fat content and bone density.
- A brief clinical history will be obtained, including data on kidney stone episodes, procedures, and current stone burden.
- 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).
- Urine supersaturations for calcium oxalate, calcium phosphate, and uric acid will be calculated using EQUIL2 software.
- Urine albumin and creatinine will be measured.
- Remaining urine will be stored at -80°C for potential future assays.
Blood:
- Serum glucose will be measured at the CRC laboratory.
- 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.
- Other serum chemistries (electrolytes, calcium, creatinine, HbA1c, lipids) will be measured at the clinical laboratory.
- Remaining serum will be stored at -80°C.
- Conditions
- Kidney Stone, Stone, Kidney
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 week total, one half day in the CRC
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: Time Frame: 1 week total, one half day in the CRC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start30 Jun 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Prochaska, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436235
- Sponsor's protocol ID
- IRB24-0024
- Status last verified
- Jul 2026
- First submitted
- 3 May 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Insulin Resistance in Kidney Stone Patients
- ClinicalTrials.gov ID
- NCT06436235
- Acronym / sponsor ID
- IRB24-0024
- Conditions
- Kidney Stone, Stone, Kidney
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- One week prior, participants will discontinue vitamin C, multivitamins, calcium supplements, and diuretics.
- One day prior, participants will complete a 24-hour urine collection and food frequency questionnaire at home.
Study Visit:
- Participants will be admitted to the University of Chicago's Clinical Research Center (CRC) in a fasted state.
- Three timed (45 minute) urine and blood specimen collections will occur.
- Three seated blood pressure measurements will be taken.
- Anthropometric measurements including height, weight, waist and neck circumference will be obtained.
- A dual-energy X-ray absorptiometry (DEXA) scan will be performed to measure visceral fat content and bone density.
- A brief clinical history will be obtained, including data on kidney stone episodes, procedures, and current stone burden.
- 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).
- Urine supersaturations for calcium oxalate, calcium phosphate, and uric acid will be calculated using EQUIL2 software.
- Urine albumin and creatinine will be measured.
- Remaining urine will be stored at -80°C for potential future assays.
Blood:
- Serum glucose will be measured at the CRC laboratory.
- 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.
- Other serum chemistries (electrolytes, calcium, creatinine, HbA1c, lipids) will be measured at the clinical laboratory.
- Remaining serum will be stored at -80°C.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- Stone formers:
- Age 18-70
- History of at least one calcium-based kidney stone
- Healthy Controls:
- Age 18-70
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 1 week total, one half day in the CRC
Levels of visceral fat as measured by dual x-ray absorptiometry (DEXA).
Difference in inflammatory markers between participants who form kidney stones and controls
Time frame: 1 week total, one half day in the CRC
Markers of systemic inflammation, including high-sensitivity CRP, interleukin-6, MMP-7, MMP-9, TNF-alpha, and endotrophin.
5 secondary outcomes
Correlation between visceral fat and inflammatory markers
Time frame: 1 week total, one half day in the CRC
Differences in urine composition
Time frame: 1 week total, one half day in the CRC
Differences in visceral fat levels
Time frame: 1 week total, one half day in the CRC
Differences in insulin resistance between kidney stone patients and controls
Time frame: 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: Time Frame: 1 week total, one half day in the CRC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Prochaska, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Stone, Kidney, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Prochaska, MD (773-702-1000 ext. 45488, mprocha2@medicine.bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 week total, one half day in the CRC). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.