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Research on Early Warning and Diagnosis & Treatment Pathway for Micro Kidney Stones

Research on Early Warning and Diagnosis & Treatment Pathway for Micro Kidney Stones

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07350369
Enrollment
20
Registered
2026-01-20
Start date
2025-08-01
Completion date
2026-03-09
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone

Brief summary

Exploring abnormal metabolism in kidney stone patients and developing drugs for kidney stone treatment and their mechanisms of action.

Detailed description

For eligible subjects who meet the inclusion and exclusion criteria, one tube (approximately 4 mL each) of blood and urine samples collected prior to surgery during hospitalization and already tested in clinical laboratories will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing, for further targeted metabolomics analysis. By analyzing the results of targeted metabolomic profiling of amine-related substances, differences in amines and metabolites in blood and urine between kidney stone patients and healthy individuals will be assessed. By measuring and comparing the levels of amine compounds in blood and their corresponding metabolites in urine, statistical analysis will be performed to identify specific amines that are elevated in blood and whose metabolites are simultaneously increased in urine. The underlying mechanisms of these elevations will be further investigated through experimental studies.

Interventions

OTHERDetect the levels of metabolites in blood and urine

Detect the levels of metabolites in blood and urine

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Case Group * Inpatients treated in the Department of Urology at Xijing Hospital with a diagnosis of renal calculi confirmed by imaging examinations, including abdominal plain radiography, ultrasonography, or computed tomography (CT). * Aged between 18 and 70 years, regardless of sex. * Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes. * Complete medical records available, including medical history, clinical symptoms, physical examination findings, previous treatments, and other relevant information. Control Group * Inpatients treated in the Department of Urology at Xijing Hospital with no evidence of kidney stones or other urological diseases, as confirmed by urinary system ultrasonography, abdominal plain radiography, or urinary CT. * Aged between 18 and 70 years, with sex distribution matched to the case group. * Willing to participate in the study and providing informed consent for the use of residual blood and urine samples (remaining after routine clinical testing) for research purposes. * No history of kidney stones or other urological diseases.

Exclusion criteria

* Presence of severe systemic diseases that may affect kidney stone formation, including malignant tumors, heart failure, liver failure, or renal failure (serum creatinine \> 354 μmol/L). * Presence of other urological diseases, such as pyelonephritis, renal tuberculosis, renal cysts, or renal tumors. * Presence of endocrine disorders, including hyperparathyroidism or hyperadrenocorticism. * Pregnant or lactating women. * Patients with psychiatric disorders, individuals unable to cooperate with the study, or those with a history of substance abuse or alcoholism. * History of surgical intervention or extracorporeal shock wave lithotripsy (ESWL) for kidney stones within the past 3 months. * Current use of medications that may influence kidney stone formation (e.g., diuretics, vitamin D, or calcium supplements) and inability to discontinue these medications. * Insufficient blood or urine sample volume to meet analytical requirements, or samples that were severely contaminated or of poor quality and unsuitable for analysis.

Design outcomes

Primary

MeasureTime frameDescription
Using liquid chromatography to measure the levels of 21 neurotransmitters and 5 biogenic amines in the blood, as well as 51 gut microbiota-derived metabolites in the urine, of patients with kidney stones and those without.25.08.01-25.11.01Blood and urine samples were collected from kidney stone patients and non-stone controls. Absolute concentrations of 21 neurotransmitters (e.g., dopamine, L-tyrosine, serotonin, 5-HIAA, tyramine) and 5 biogenic amines (spermidine, spermine, putrescine, ornithine, arginine) in blood, and 51 gut microbiota-derived metabolites (e.g., uric acid, shikimic acid, L-tryptophan, indoxyl-β-D-glucoside, 4-hydroxyphenylacetic acid, etc.) in urine were quantified using liquid chromatography. All concentrations are reported in ng/g. Statistical analyses compared metabolite levels between groups and assessed their associations with kidney stone disease.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORzhang ke ying zhang, doctor

中国人民解放军空军军医大学第一附属医院

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026