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临床试验/CTRI/2018/03/012528
CTRI/2018/03/012528已完成不适用

Role of specific inflammatory markers and adipokines in relation to insulin resistance and β-cell function.

India Diabetes Research Foundation1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2016年4月4日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
1
主要终点
Differences between baseline levels of visfatin resistin chemerin and fetuinA in cases developing T2DM and in normoglycaemia

研究概览

简要总结

The pathogenesis of diabetes explains the fact that early inflammatory and immune mechanisms are elemental in the disease progression predisposing the condition to diabetes. The currently available gold standard clinical markers of diabetes; fasting blood glucose, oral glucose tolerance test and HbA1c efficiently reflects blood glucose status but does not provide an elaborate information on the pathological process involved in the early stages of the disease.

There is a complex cluster of factors associated with diabetes; insulin resistance, hyperglycaemia, dyslipidaemia, hypertension, hyperinsulinaemia, systemic inflammation and adipose-tissue derived compounds. It is evident that no single factor can precisely assess the individuals risk status of diabetes. The inflammatory and immune marker profile varies in the course of the development of the disease. This heterogeneity enables differentiation between the early preclinical and clinical phases of its progression. Identification of novel biomarkers presented at the initial stages of subclinical inflammation may be used to refine diabetes risk prediction and target individuals for suitable intervention.

It is important to correlate clinical markers of glucose levels (fasting plasma glucose, HbA1c), markers of metabolism (resistin, visfatin) and inflammatory markers (CD 36, CD 26) to present a lucid representation of the risk profile of diabetes. Therefore a prospective study in subjects with prediabetes is being taken up with the objective to study the above parameters that are likely to have a significant role with the interrelated metabolic conditions of insulin resistance and β-cell function. For the proposed study the population will be incident T2DM cases (n=80) as defined by the WHO criteria of HbA1c ≥6.5% and those reverted to normoglycaemic status HbA1c <5.7% (n=80). When combined the study of biomarkers will be performed in 160 samples.   Circulating levels of sCD36, sCD26, serum visfatin and serum resistin will be analysed using commercial kits for Enzyme linked Immuno Sorbent Assay (ELISA).  If these markers are identified as independent predictors of insulin resistance, they can serve as suitable tools to be applied in disease prognosis for prediabetes and cardiovascular risk. This is an exploratory analysis of the main study entitled “A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent Type 2 diabetes in India and the UKâ€, CTRI/2014/07/004799.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
35.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Both Men and women with no history of diabetes Persons with 3 or more of the following risk factors for diabetes a Age 35 to 55 years b Positive family history of diabetes c Body mass index greater than 23kg per m2 d Waist circumference more than 90cm for men and more than 80cm for women e Hypertension f Sedentary habits Persons with prediabetes having HbA1c values between 6 percent and less than 6 point 5 percent.

排除标准

  • Known diabetes Any other illness Unwilling to participate.

结局指标

主要结局

Differences between baseline levels of visfatin resistin chemerin and fetuinA in cases developing T2DM and in normoglycaemia

时间窗: 24 months

次要结局

  • Effect of lifestyle factors on study parameters(Association of visfatin resistin chemerin and fetuinA with insulin resistance and β-cell function.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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