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临床试验/NCT04891887
NCT04891887已完成不适用

Diabetes Mellitus and microRNA as Risk Factors for Mild Cognitive Impairment: Impact of Life Style Modification

National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
163
试验地点
1
主要终点
HbA1c

研究概览

简要总结

This is a 2-step study; 1st step was a cross sectional study carried out on 163 consecutive Type 2 Diabetes Mellitus (T2DM) patients employee attending outpatient clinics of the National Research Center (NRC), Egypt. A face-to-face interview was carried out to collect data about demographic data and medical history. Cognitive function assessment was carried out using Adenbrooke's Cognitive Examination III (ACE III) test and the Trail Making Test (TMT) which consists of two parts (A and B). Quality of life and depression were also assessed using Short Form-36 (SF-36) and Hamilton Depression Rating Scale (HRDS) questionnaires respectively. The second step was an interventional study for health education and life style modification. The main outcome measures were Fasting Blood Glucose (FBG), HbA1c, total blood cholesterol, HDL cholesterol, LDL cholesterol and triglycerides, oxidant and antioxidant (Malondialdehyde (MDA), glutathione peroxidase (GPx), glutathione reductase (GR)) which were assessed at baseline and reassessed after the intervention.

详细描述

The current study was carried out during the period from February 2016 to June 2019 on two steps.

  1. First step (baseline assessment): It was a cross sectional study carried out on 163 Type 2 Diabetes Mellitus (T2DM) patients attending outpatient clinics at NRC. Patients were 65 males and 98 females; aged from 40 to 65 years. All patients were literate and were able to complete the tests of cognitive function. The exclusion criteria were T2DM patients with history of head trauma, stroke, transient ischemic attack, brain tumor, epilepsy, psychiatric disease, cardiac or liver failure and visual or hearing disabilities. Approval of NRC ethical committee was obtained with registration number 15131. Participants signed a written informed consent before being included in the study.

1.1 A face to face interview was carried out with all participants to collect data about demographics, medical history and cognitive function. Data included age, gender, level of education, and tobacco smoking. Detailed medical history of diabetes was taken from patients including age of diagnosis of diabetes, frequency of hypoglycemic attacks, type of treatment (insulin or oral hypoglycemic drug), history of hypertension, dyslipidemia or other diseases and medications taken. Any complaint suggestive for presence of sensory peripheral neuropathy such as tingling, burning pain or numbness in hands and feet was recorded. All studied participants were subjected to thorough clinical examination, systolic and diastolic blood pressure and anthropometric assessment (weight and height measurements).

1.2 Assessment of cognitive function with its domains was carried out using Adenbrooke's Cognitive Examination III (ACE III) test which assesses five cognitive domains: attention, memory, verbal fluency, language and visuospatial abilities. It is the most reliable and validated Arabic form cognitive scale and freely available to be applied. Objective mild cognitive impairment (MCI) was considered if ACE III score is less than 88. The Trail Making Test (TMT) was also used. TMT is one of the most widely used instruments in neuropsychological assessment as an indicator of speed of cognitive processing and executive functioning. It assesses attention, concentration, psychomotor speed, cognitive shifting and complex sequencing function by measuring the time required to connect a series of sequentially numbered and lettered circles. The test consists of two parts (A and B). The direct score of each part is represented by the time of completion of the tasks. Shorter time indicates better cognitive function.

1.3 Hamilton Rating Scale for Depression (HRSD) was used, it is one of the most widely used scales that objectively rate depression severity. The scale includes 17 items, each one is scored on a 3 or 5 points scale, with the final score indicative of the severity of the patient's depression. The classification of depression level was carried out depending on the National Institute for Health & Clinical Excellence of the United Kingdom (UK) (0-7 = Normal, 8-13 = Mild depression, 14-18 = Moderate depression, 19-22 = Severe depression and ≥ 23 = Very severe depression).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • T2DM patients attending outpatient clinics of Medical Services Unit of the National Research Center (NRC).

排除标准

  • T2DM patients with history of head trauma, stroke, transient ischemic attack, brain tumor, epilepsy, psychiatric disease, cardiac or liver failure and visual or hearing disabilities

结局指标

主要结局

HbA1c

时间窗: 6 months

HbA1c

Cognitive function

时间窗: 6 months

Total score of Adenbrooke's Cognitive Examination III. Minimum value= 0, maximum value= 100 and higher scores mean a better outcome.

Depression

时间窗: 6 months

Hamilton Rating Scale for Depression score. Minimum value= 0, maximum value= 53 and higher scores mean a worse outcome.

Health related quality of life

时间窗: 6 months

Short Form-36 (SF-36) questionnaire score. Minimum value= 0, maximum value= 100 and higher scores mean a better outcome.

次要结局

  • Glutathione Reductase(6 months)
  • Glutathione Peroxidase(6 months)
  • Total serum cholesterol(6 months)
  • Mental activity(6 months)
  • Hypoglycemic attacks(6 months)
  • LDL(6 months)
  • HDL(6 months)
  • Social activity(6 months)
  • Body weight(6 months)
  • Triglycerides(6 months)
  • Trail Making Test(6 months)
  • Medication compliance(6 months)
  • Malondialdehyde(6 months)
  • Fasting blood glucose(6 months)
  • Healthy dietary intake(6 months)
  • Physical activities(6 months)

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

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