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临床试验/NCT03273738
NCT03273738Unknown不适用

Assessment of Vascular and Metabolic Changes in Post-menopausal Women With Type 2 Diabetes Mellitus

Assiut University0 个研究点目标入组 100 人开始时间: 2018年10月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
metabolic changes in type 2 diabetes

研究概览

简要总结

The presence of type 2 diabetes mellitus (T2DM) also increases the relative risk of developing cardiovascular disease in women compared to men. Carotid intima media thickness (IMTc) was increased with reduction in brachial artery flow-mediated dilation (FMD) in T2 DM patients and inversely and strongly related to the extent of hyperglycemia. Low concentrations of folate and vitamin B12 involved in homocysteine metabolism are also associated with increased risk of vascular damage. the aim is to relate, if found, the degree of metabolic changes to the extent in vascular parameters changes in type 2 diabetic postmenopausal women.

详细描述

Introduction Complications of diabetes, such as cardiovascular disease, are associated with increased mortality among type 2 diabetes mellitus patients. The presence of type 2 diabetes mellitus (T2DM) also increases the relative risk of developing cardiovascular disease in women compared to men . Major cardiovascular disease risk factors that have been identified in T2DM patients include arterial stiffening, endothelial dysfunction, hyperglycemia , and elevated glycated haemoglobin (HbA1c) concentrations.

Cardiovascular disease is the major cause of morbidity and mortality in T2 DM, due to arterial structure and functional changes. Evaluation of vascular dysfunction in T2 DM patients include: carotid intima media thickness (IMTc), pulse wave velocity (PWV), and brachial artery flow-mediated dilation (FMD). IMTc is increased in patients with T2 DM with reductions in FMD, which have already been reported to be inversely and strongly related to the extent of hyperglycemia.

The incidence of vascular complications is multifactorial and may not be explained by hyperglycemia alone. Other presumably unrelated risk factors, such as hyperhomocysteinemia may be involved in the atherothrombotic process. High levels of homocysteine have been identified as a risk factor for cardiovascular disease in T2DM patients. Levels of plasma homocysteine increase in women after menopause, and postmenopausal diabetic women are consequently at significantly increased risk of cardiovascular disease.

High concentrations of homocysteine are associated with increased low-density lipoprotein oxidation, endothelial dysfunction, dysfunction of β-islet cells and inhibiting secretion of insulin. Also, hyperhomocysteinemia was an independent risk factor for the occurrence of diabetic peripheral neuropathy .

In newly diagnosed normotensive T2DM patients, the left ventricular mass index (LVMI), carotid intima media thickness (CIMT), and creatinine levels and 24-hr microalbuminuria were used to determine cardiac, carotid, and kidney end-organ diseases, respectively. It was found that, LVMI, CIMT, and creatinine level were positively correlated with the homocysteine level.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • post-menopausal women
  • aged 50-70 years
  • amenorrhea for over 24 months.
  • The diabetic participants will receive their treatment for T2DM (oral hypoglycemic agents or insulin).

排除标准

  • Patients receiving hormone replacement therapy.
  • History of abnormal vaginal bleeding.
  • Patients receiving vitamin B12, vitamin D and folic acid regularly.
  • History of malignancy or neurological diseases as epilepsy, parkinsonism and Alzheimer disease.
  • Antifolate medications as methotrexate are excluded from the study.

结局指标

主要结局

metabolic changes in type 2 diabetes

时间窗: baseline and 3 months

B12 level and their relation to complications

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohammed

principal investigator

Assiut University

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