Research on Early Warning and Diagnosis & Treatment Pathway for Micro Kidney Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Exploring abnormal metabolism in kidney stone patients and developing drugs for kidney stone treatment and their mechanisms of action.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nephrolithiasis
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 will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed.
干预措施: Detect the levels of metabolites in blood and urine (Other)
Normal
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 will be gathered. Serum will be separated from the blood samples, while the entire urine sample will be submitted without processing. These samples will undergo further targeted metabolomics analysis. By measuring amine-related substances using targeted metabolomics, differences in amine compounds and metabolites in blood and urine between kidney stone patients and healthy individuals will be analyzed.
干预措施: Detect the levels of metabolites in blood and urine (Other)
结局指标
主要结局
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.
时间窗: 25.08.01-25.11.01
Blood 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.
次要结局
未报告次要终点