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临床试验/NCT06385899
NCT06385899已完成不适用

The Effect of Close and Intensive Therapeutic Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

Goztepe Prof Dr Suleyman Yalcın City Hospital1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2021年8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
266
试验地点
1
主要终点
Changes in HbA1c levels after 12 months treatment

研究概览

简要总结

In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c >=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months.

详细描述

Patients who applied to Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital Diabetes Polyclinics and have an HbA1c levels of >= 10% in their examinations will be admitted to the study. Detailed history, including medication usage and previous blood tests will be questioned. The patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (General practice physical activity questionnaire), and whether the participants have depression (Beck depression questionnaire). Anthropometric measurements will be taken, and biochemical data will be recorded. Patients will be grouped according to their previous HbA1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. Diabetes follow-up will be continued by their respective physicians. The patients will be called again three months after their enrollment to record the most recent biochemical data. Patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined HbA1c groups. Again, according to the patient groups, the difference in HbA1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed with type 2 diabetes
  • •give consent to the study
  • •accessibility to the previous and recent test results

排除标准

  • •acute infection or inflammation lasting more than a week
  • •acute metabolic decompensation
  • •unable to attend to the follow-ups
  • •having non-thyroid endocrine diseases
  • •active oncologic treatment

结局指标

主要结局

Changes in HbA1c levels after 12 months treatment

时间窗: twelve months

Changes in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups.

percentage of patients who reached the HbA1c target of equal to or below 7%

时间窗: twelve months

Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%

次要结局

  • The effect of education on the HbA1c changes(twelve months)
  • The effect of weight loss on the HbA1c changes(twelve months)
  • The effect of the level of physical activity on the HbA1c changes(twelve months)
  • The effect of depression on the HbA1c changes(twelve months)

研究者

发起方
Goztepe Prof Dr Suleyman Yalcın City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse N Erbakan

The Principal Investigator

Goztepe Prof Dr Suleyman Yalcın City Hospital

研究点 (1)

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