跳至主要内容
临床试验/CTRI/2025/11/097671
CTRI/2025/11/097671尚未招募不适用

Monocyte-to-HDL Cholesterol Ratio as a Marker of Proteinuria in Pre-Diabetes and Type 2 Diabetes Mellitus

KMC Manipal1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年11月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Proteinuria

研究概览

简要总结

The Monocyte-to-HDL cholesterol ratio is an emerging marker of inflammation, high values of which have been linked to metabolic syndrome, cardiovascular mortality and endothelial dysfunction. This ratio is of particular relevance in diabetic kidney disease due to its pathogenesis involving recruitment of monocytes, and the countering effect of HDL by inhibiting the proliferation and maturation of monocytes, making the MHR a reflection of the overall inflammatory milieu in the kidney in diabetics. Also, while proteinuria is a well-established marker of diabetic kidney disease, pre-diabetics have also been observed to develop proteinuria without decline in eGFR, thus prompting the possibility of pathological renal changes even in pre-diabetics, and promoting screening in this subset of the population.

Patients will be recruited from the Department of Medicine. Following informed consent, they will be asked questions pertaining to their medical history and also undergo a basic physical examination for assessing BMI and vitals. For BP, the average of two recordings taken 15 minutes apart will be considered. They will then be asked to provide a fasting blood sample for fasting glucose, HbA1c, CBC, urea, creatinine, fasting lipid profile, and mid-stream urine sample for microscopy, routine analysis, random protein and random creatinine. Proteinuria will be assessed using UPCR. eGFR will be calculated using the 2021 CKD-EPI equation, and used as an outcome measure for decline in renal function. Patients will be divided into diabetic and pre-diabetic groups, and further sub-groups based on the degree of proteinuria. First, within the diabetic group, the researcher will assess the independent relations of diabetic control and MHR with proteinuria. Second, the degree of proteinuria and the MHR between diabetics and pre-diabetics will be compared. Third, the eGFRs of all subjects will be calculated and compared with the respective MHRs to detect any association between MHR and decline in renal function.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age more than or equal to 18 years 2) Patients who have HbA1c more than or equal to 5.6% OR a fasting glucose level of more than 126 mg/dl 3) Known diabetics/ pre-diabetics on treatment (lifestyle and/or medication) with good diabetic control, not meeting inclusion criteria 2.

排除标准

  • Patients who have other systemic diseases that may lead to proteinuria or impaired eGFR i.e a.
  • Acute infections b.
  • Chronic infections like HIV, Tb c.
  • Malignancies d.
  • Autoimmune disorders e.
  • Severe hepatic dysfunction f.
  • Congestive heart failure g.
  • Acute kidney injury h.
  • Uncontrolled hypertension (BP more than or equal to 140/90) 2) Type 1 diabetics 3) Patients in diabetic ketoacidosis or hyperosmolar nonketotic state.

结局指标

主要结局

Proteinuria

时间窗: End of study

次要结局

  • eGFR as a measure of renal function(End of study)

研究者

发起方
KMC Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shreya A Bhat

Kasturba Medical College Manipal

研究点 (1)

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