Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436235
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-03
Brief Title:
Kidney Stone Inflammation
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Inflammation and Insulin Resistance in Kidney Stone Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont have diabetes and 20 healthy people who havent 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
The study will recruit 20 people who have had calcium kidney stones but dont have diabetes and 20 healthy people who havent 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 Chicagos 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
124-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 -80C 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 -80C
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 Chicagos 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
124-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 -80C 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 -80C
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None