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临床试验/CTRI/2025/08/093714
CTRI/2025/08/093714尚未招募不适用

Assessment of risk factors influencing poor glycemic control among type 2 diabetes patients with coronary artery disease: a retrospective study

NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 1,080 人开始时间: 2025年9月12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
1,080
试验地点
1
主要终点
HbA1c levels

研究概览

简要总结

INTRODUCTION

Diabetes is a major health concern worldwide, with high morbidity, disability, mortality, and impaired quality of life. Glycemic control is the important strategy to reduce complications of type 2 diabetes. About 462 million individuals worldwide are affected with T2DM People those who are affected with T2DM and CAD have higher cardiac risk.

NEED FOR STUDY

T2DM and CAD are frequently coexisting conditions and their combination significantly increases the risk of adverse health outcomes. There is a well-defined relationship between increase HbAlc levels and the incidence of CAD, it is estimated that one third of patients undergoing PCI have T2DM. By identifying the most effective HbA1c management strategies reduces the health care expenses while improving patient outcomes.

OBJECTIVE OF THE STUDY:

To determine the predisposing risk factors of CAD in diabetes patients with HbA1c less than and equal to 7 and HbA1c greater than 7.

METHODOLOGY

The retrospective observational study will be conducted for 8 months. Participants included in the study will be patients above the age of 18 of either gender with T2DM and CAD will be carried out in the Department of General medicine, Endocrinology and Cardiology of Justice K S Hegde Charitable hospital Mangalore. The permission from Institutional Ethics Committee will be obtained before the study**.**

STATISTICAL ANALYSIS

Qualitative data will be expressed as mean ±SD/Median (IQR). Quantitative data will be expressed as frequency in percentages. Pearson Chi-square test/Fisher exact test will be used to find the association between categorical variables P<0.05 will be considered statistically significant. SPSS software version 29 will be used for statistical analysis.

OUTCOME MEASURES

It is important to identify and analyze the risk factors contributing the development of CAD in patients with poor glycemic control in this population.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients who are diagnosed with type 2 diabetes mellitus with coronary artery disease.
  • Age of the patients are above 18 years.
  • Coronary artery disease should be confirmed by angiography findings only.

排除标准

  • Patients who are diagnosed with type 1 diabetes,patients who are pregnant, patients who are on dialysis or severe kidney disorders.Patients having history of CABG surgery.

结局指标

主要结局

HbA1c levels

时间窗: 8 months

次要结局

  • Predictors considered in the study are age,gender, blood pressure, estimated GFR, current smoking status,ST segment depression,ST segment elevation,Q waves ,sodium ,Potassium , lipid levels & antidiabetic drugs(8 months)

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

Kshama K Chouta

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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