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临床试验/CTRI/2025/11/097950
CTRI/2025/11/097950尚未招募不适用

Evaluation of Serum Ceruloplasmin and Triglyceride/HDL-C ratio in Patients with Diabetic Retinopathy

Dr Swarna Paliwal1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年12月15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
180
试验地点
1
主要终点
To measure the serum ceruloplasmin levels and TG/HDL-C ratio in type 2 Diabetes Mellitus (DM) patients without DR, type 2 DM with DR and age- and sex-matched non-diabetic controls

研究概览

简要总结

PROJECT SUMMARY

Title of the Study: Evaluation of Serum Ceruloplasmin and Triglyceride/HDL-C Ratio in Patients with Diabetic Retinopathy

  • This study will be done to evaluate the potential roles of serum ceruloplasmin levels and the triglyceride/high-density lipoprotein cholesterol (TG/HDL-C) ratio in patients with diabetic retinopathy (DR).
  • The study will be conducted in the Department of Biochemistry, in collaboration with the Department of Medicine and Department of Ophthalmology, at RUHS College of Medical Sciences (RUHS-CMS) and associated hospitals in Jaipur.
  • Study Type: Cross-sectional comparative study.
  • Study Duration: 1 year.

·         Study universe: 20 DR patients out of around 40 DR patients from  an average of 95-100 DM patients attending one medicine OPD at Department of Medicine, associated hospital RUHS-CMS, Jaipur per month

  • Age Group: 30 to 70 years of age, both male and female participants.

  • Study Groups:

  • Group 1: 60 T2DM patients diagnosed with diabetic retinopathy (any sign of DR such as microaneurysm, dot blot hemorrhages, venous bleeding, or neovascularization).

  • Group 2: 60 T2DM patients without diabetic retinopathy.

  • Group 3: 60 healthy individuals without diabetes (age and sex-matched controls).

  • Sample Size: 180 participants (60 from each group).

  • The primary aim of this study is to investigate the relationship between serum ceruloplasmin levels, TG/HDL-C ratio, and the presence and severity of diabetic retinopathy in Type 2 DM patients.

  • By identifying individuals at risk for DR, early intervention strategies can be employed to prevent or slow the progression of the disease, thus preserving vision and improving the quality of life for diabetic patients.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • patient confirmed with type 2 diabetes mellitus.

排除标准

  • Patient having retinopathy other than DR
  • Use of medications that could influence serum ceruloplasmin levels or lipid profiles, such as corticosteroids or lipid-lowering agents.
  • Patient with coexisting diabetic nephropathy
  • Patients with history of recent surgery/trauma/infection/inflammation 5.Patient with severe hepatic/renal diseases 6.Pregnant or breastfeeding women.

结局指标

主要结局

To measure the serum ceruloplasmin levels and TG/HDL-C ratio in type 2 Diabetes Mellitus (DM) patients without DR, type 2 DM with DR and age- and sex-matched non-diabetic controls

时间窗: 1 YEAR

次要结局

  • 1.To analyse the differences in serum ceruloplasmin levels & TG/HDL-C ratio among non-diabetic controls, diabetic patients without DR, diabetic patients with DR

研究者

发起方
Dr Swarna Paliwal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Swarna Paliwal

RUHS college of medical sciences,jaipur

研究点 (1)

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