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临床试验/CTRI/2019/09/021398
CTRI/2019/09/021398尚未招募不适用

A STUDY ON ASSESSMENT OF METABOLIC SYNDROME IN TYPE II DIABETES MELLITUS PATIENTS

MERLIT JAMES1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年1月10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
350
试验地点
1
主要终点
occurrence of metabolic syndrome among patients with type II DM

研究概览

简要总结

Diabetes Mellitus (DM) is a metabolic disease defined by hyperglycaemiadue to defects in insulin secretion, insulin action, or both. The predominanceof diabetes has increased worldwide in both genders equally . There is adramatic increase in the ubiquity of diabetes owing to modernization andurbanization that has brought about a substantial burden on the health careservices. Metabolic syndrome (Met S) is defined as a cluster of cardiovascularrisk factors which include raised fasting plasmaglucose, central obesity, and hypertension,raised triglycerides, and reduced HDL cholesterol . Also known as syndrome X or insulinresistance syndrome, it has been recognized since 1980s. The guidelines for thediagnosis of metabolic syndrome have been given by different organizations suchas World Health Organization (WHO), International Diabetic Federation (IDF),and National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) imparted a new working definition of the metabolic syndrome and thus, itis easily applicable and provides strong clinical evidence. The MetS is influenced by several factors, someof which can accelerate the disease’s progression to various complications thataggravate the morbidity.

DM is associated with a three to five fold increased risk forthe development of Metabolic Syndrome (Met S) which has now reached highproportions in many countries. MetS is known to be caused by insulin resistanceor insulin resistance-linked obesity, a condition whereby the body’s cells areincapable of taking up glucose from the blood. Insulin resistance-linkedobesity is caused by poor dieting and lack of regular exercise. Other geneticor lifestyle risk factors equally lead to the metabolic Met S. This leads tothe development of macroand micro vascular complications in patients with Diabetes Mellitus. There is little information on MetS causes andpredictor factors, due to few published data on the prevalence of Met S and itsassociation with type II diabetes mellitus. There are difference in the prevalence of metabolic syndromein different ethnic population due to difference in lifestyle, distribution ofdifferent risk factors, knowledge and awareness about metabolic diseases. Theprimary objective of the study is to identify the occurrence of Metabolic Syndrome(Met S) among type II DM patients. Secondary objective is to assess the genderrelated difference in risk factors associated with metabolic syndrome. Theproposed study will help to identify the occurrence of metabolic syndrome amongDM population and will help to understand the association between eachcomponents of metabolic syndrome with gender. Identification of MetS inpatients with DM will be useful in predicting other complications and it willhelp to devise more targeted interventions.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • patients on diabetic treatment.

排除标准

  • Type I Diabetes Mellitus.
  • Seriously ill patients, who were under ventilation support and in altered mental status.
  • Patients not giving consent.
  • Pregnant women.

结局指标

主要结局

occurrence of metabolic syndrome among patients with type II DM

时间窗: 8 months

次要结局

  • gender related difference in risk factors among patients with type II DM(8 months)

研究者

发起方
MERLIT JAMES
申办方类型
Other [self]

研究点 (1)

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