"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
2020年11月16日 更新者：Viktoriya Li、Astana Medical University
Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients
研究概览
详细说明
Patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are:
- changing the meal plan (individual and group counseling, assistance in developing menus and determining the calorie intake, keeping a food diary)
- individually dosed physical exercises using specific exercise program;
- comprehensive training (course of interactive lessons, self-control training). The program included group sessions with a team of specialists: nutritionist, endocrinologist, physical therapy doctor and included 3 sessions per week for 24 weeks. Each visit included teaching patients in a group format and in an interactive form (classes with specialists alternated), performing physical exercises using the specific exercise program under the supervision of a physiotherapy physician, evaluating medical indicators, and a self-control diary.
Patients in the control group will not participate in group sessions, but they had the opportunity to receive non-pharmacological care provided in the framework of free outpatient care. Their indicators will be recorded during a routine visit to the doctor at the baseline, after 12 and 24 weeks.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Moscow、俄罗斯联邦、101000
- 主动，不招人
- National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation
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Astana、哈萨克斯坦、010000
- 招聘中
- Astana Medical University
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接触：
- Yerbolat Dalenov, Professor
- 电话号码：+77017694241
- 邮箱：dalenov.e@amu.kz
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副研究员：
- Anna Bazarova, Docent
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Astana、哈萨克斯坦、010000
- 招聘中
- The Center for Preventive Medicine and Life Extension of Nur-Sultan
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接触：
- Viktoriya Li, PhD
- 电话号码：+77785568055
- 邮箱：liviktoriya0509@gmail.com
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Aktobe Region
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Aktobe、Aktobe Region、哈萨克斯坦、030000
- 主动，不招人
- West Kazakhstan Marat Ospanov Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 59年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- medically diagnosed with type 2 diabetes mellitus
- HbA1c result of ≤7.0% within the past 2 months
- body mass index (BMI) of ≥26 kg/m^2
- hypoglycemic therapy: metformin only
Exclusion Criteria:
- pregnancy
- the use of other hypoglycemic drugs
- the use of medication for weight loss
- cardiovascular diseases (heart attack or cardiac procedure within the past 3 months)
- had stroke or history of treatment for transient ischemic attacks in the past 3 months
- had chronic renal failure or were on dialysis
- any conditions that do not allow the patient to perform the complex of the proposed physical exercises
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Comprehensive non-pharmacological program intervention
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
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dietary supplement, specific type of exercise, self-management education
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无干预：Usual diabetes care
This group is control, the patients receive usual diabetes care routines.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline Glycosylated Hemoglobin at 6 months
大体时间：at baseline and at 24-week postrandomization
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HbA1c value
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at baseline and at 24-week postrandomization
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Change from Baseline Body Mass Index at 6 months
大体时间：at baseline and at 24-week postrandomization
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BMI
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at baseline and at 24-week postrandomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Blood Pressure at 6 months
大体时间：at baseline and at 24-week postrandomization
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Systolic and diastolic blood pressure at the brachial artery
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at baseline and at 24-week postrandomization
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Change from Baseline Lipid Profiles at 6 months
大体时间：at baseline and at 24-week postrandomization
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Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
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at baseline and at 24-week postrandomization
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Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)
大体时间：at baseline and at 24-week postrandomization
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Homeostasis ModelAssessment of Insulin Resistance
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at baseline and at 24-week postrandomization
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Viktoriya Li, PhD、Astana Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月1日
初级完成 (预期的)
2021年2月1日
研究完成 (预期的)
2021年6月1日
研究注册日期
首次提交
2020年11月9日
首先提交符合 QC 标准的
2020年11月16日
首次发布 (实际的)
2020年11月17日
研究记录更新
最后更新发布 (实际的)
2020年11月17日
上次提交的符合 QC 标准的更新
2020年11月16日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.