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临床试验/NCT02021695
NCT02021695已完成不适用

DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
249
试验地点
1
主要终点
DNA methylation and gene expression in blood monocytes and lymphocytes

研究概览

简要总结

With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the investigators intend to measure the changes in DNA methylation and gene expression in blood monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are persistent or can be reversed by improving diabetes control.

详细描述

The global prevalence of Type 2 Diabetes (T2D) is rapidly rising throughout most regions of the developed and developing world. In Middle East countries, particularly in the Gulf Council countries, the diabetes pandemic along with the rates of obesity have risen due to the adoption of a modern lifestyle. In the Qatari population alone, T2D is highly prevalent as 18% of the Qatari adults are estimated to suffer from this disease. Consanguineous marriages, sedentary lifestyle, obesity and bad dietary habits are cited as the main causes for this high incidence rate. Chronic hyperglycemia caused by long-term uncontrolled diabetes state can lead to devastating complications such as cardiovascular diseases, neuropathy, and retinopathy. Such complications are also highly prevalent in the Qatari population, perhaps due to the relatively low adherence to clinical guidelines but vary among Qatari individuals based on their genetic predisposition and shared family environment.It is already known that inflammation is part of the complex biochemical process of initiating and further developing cardiovascular complications of diabetes. Experimental models have showed that exposure to hyperglycemia induces epigenomic changes in inflammatory pathways, which subsequently regulate gene expression leading to the development of vascular inflammation. The investigators therefore hypothesized that chronic hyperglycemia leads to altered DNA methylation and dysregulation of gene expression in peripheral blood monocytes and lymphocytes in patients with type 2 diabetes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must provide informed consent
  • Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
  • In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity)
  • Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).

排除标准

  • Diagnosis of Type-I Diabetes
  • Active situational diabetes (steroids use/pregnancy)
  • Active infection or acute illness of any kind
  • Chronic inflammation (auto-immune diseases) or infection
  • Evidence of malignancy within the past 5 years
  • Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies (e.g. sickle cell disease and thalassemia), increases red-cell turnover (e.g. hemolytic anemia and spherocytosis.
  • Evidence of malignancy within the past 5 years
  • Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies

结局指标

主要结局

DNA methylation and gene expression in blood monocytes and lymphocytes

时间窗: 1 hour

Changes in DNA methylation and gene expression in blood monocytes and lymphocytes will be compared in healthy, diabetic and pre-diabetic subjects.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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