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临床试验/CTRI/2025/07/091566
CTRI/2025/07/091566尚未招募不适用

Prediction of cardiovascular disease risk in type 2 diabetes mellitus patients and assessment of health-related quality of life

NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2025年8月3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
243
试验地点
1
主要终点
Early prediction of CVD risk in type II diabetes mellitus patients will help prevent severe complications.

研究概览

简要总结

Introduction

Cardiovascular disease (CVD) is a major complication of type 2 diabetes mellitus (T2DM), significantly increasing mortality risk. Individuals with T2DM have a 2 to 4 times higher mortality risk due to CVD compared to non-diabetics. Early identification of CVD risk and assessment of quality of life are crucial in improving clinical outcomes for diabetes patients. Tools like QRISK®3 accurately predict CVD risk in T2DM by incorporating multiple clinical and demographic variables. Tools like the ADDQoL assess diabetes-specific QoL.

Objective of the study:

  • To predict the risk of cardiovascular diseases in patients with type 2 diabetes mellitus.
  • To assess the health-related quality-of-life parameters in type 2 diabetes mellitus patients.
  • To find the relationship between cardiovascular disease risk scores and quality of life scores in type 2 diabetes mellitus patients.

Methodology

The Justice K.S. Hegde Charitable Hospital in Mangalore will be the site of this cross-sectional investigation. Purposive sampling will be used to choose a sample size of 243 T2DM patients. Participants must have had diabetes for a minimum of 12 months and range in age from 25 to 84. The 10-year CVD risk will be evaluated using QRISK®3, and the QoL specific to diabetes will be assessed using ADDQoL. Prescriptions, lab reports, and interviews will all be used to gather data. Participants’ privacy will be strictly protected, and ethical approval is required.

Inclusion Criteria:

  • Patients are diagnosed with type 2 diabetes mellitus for at least 12 months.
  • Age between 25-84 years.On medications for diabetes management.
  • Patients are willing to complete questionnaires and participate in interviews to assess their quality of life.
  • Patients are not receiving treatment for cardiovascular disease.

Exclusion criteria:

  • Patients who are diagnosed with type 1 diabetes mellitus or gestational diabetes.
  • Patients with terminal illnesses.
  • Patients with psychiatric illnesses.
  • Patients with type 2 diabetes mellitus who had trauma-related amputations.

Statistical Analysis:

SPSS version 29.0 will be used to enter and analyze all of the data that has been gathered. The mean ± standard deviation or median (IQR) will be used to represent quantitative variables. Karl Pearson or Spearman rank correlation will be used to evaluate the association between QRISK®3 scores and ADDQoL scores

Outcome Measurement:

The main goal is to use the QRISK®3 tools to predict cardiovascular risk in people with type 2 diabetes. Using ADDQoL to evaluate diabetes-related quality of life. Determining a correlation between QoL scores and CVD risk is an additional measurement. These results will be useful in identifying high-risk patients who require immediate, critical care. The findings are intended to help physicians create individualized treatment programs that consider both psychological and physical factors. This research aims to improve life satisfaction, complications, and patient outcomes for diabetes.

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients are diagnosed with type 2 diabetes mellitus for at least 12 months. Age between
  • 84 years. On medications for diabetes management. Patients are open to completing questionnaires and interviews to evaluate their quality of life. Patients are not receiving treatment for cardiovascular disease.

排除标准

  • Patients who are diagnosed with type 1 diabetes mellitus or gestational diabetes.
  • Patients with terminal illnesses.
  • Patients with psychiatric illnesses.
  • Patients with type 2 diabetes mellitus who had trauma-related amputations.

结局指标

主要结局

Early prediction of CVD risk in type II diabetes mellitus patients will help prevent severe complications.

时间窗: 8 months

次要结局

  • To evaluate health-related quality of life in patients with type 2 diabetes mellitus(8 months)
  • To estimate the association between cardiovascular disease risk scores and quality of life measures in patients with type 2 diabetes mellitus(8 momths)

研究者

发起方
NGSM Institute of Pharmaceutical Sciences
申办方类型
Other [Academic Institute]
责任方
Principal Investigator
主要研究者

Aiswarya B

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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