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Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

2020年3月20日 更新者:Marmara University

First Exercise Reports of Diabetes Centre: Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

Diabetes is considered an epidemic disease with the 463 million affected patients (between 20-79 years) and it is estimated that 578 million people will have diabetes by 2030 [1]. According to The International Diabetes Federation (IDF) reports, 4,2 million adults were considered to die due to diabetes and its complications in 2019. Because of this situation, diabetes treatment is so important. The recommendations for the treatment of DM include medications and lifestyle management, which includes physical activity (PA), medical nutrition therapy, smoking cessation counseling, and psychosocial care. PA is an important aspect of management that directly under the control of the patients. So the investigators want to interrogate the effect of exercise on blood parameters, blood pressure, body compositions.

研究概览

地位

完全的

条件

详细说明

The data of the participants who came to the sports center where is prepared for the diabetes patients in the hospital will be collected from the past registration files on the electronic system.

Sociodemographic data, blood values and bio-impedance measurements of each patient are collected coming to the sports center, routinely.

Patients who had missing data, patients who did not complete the 3-month exercise program were excluded from the analysis. All analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22. 0 for Windows. Data are expressed as mean ± standard deviation. The one-sample Kolmogorov-Smirnov test was performed to assess the distribution of data. Due to their distribution, numerical variables in different subjects were compared with the t-test or Mann-Whitney U test. Comparison of variables before and after the exercise program were compared by the paired t-test (parametric variable) or Wilcoxon test (non-parametric variable). Probability values were two-tailed, and a p-value of less than 0.05 was considered as significant.

All assessments were performed in the clinic at baseline and end of the 3rd month. The blood samples were collected. The systolic and diastolic blood pressure (SBP and DBP) were measured with an automatic arm BP monitor before and after every session. Body mass and body composition, including percent body fat, fat and fat-free mass, were determined using a bioelectric impedance system with the electrodes in contact with soles and heels of both feet. At the baseline and end of the third month, the same person repeated all assessments.

Patients had recruited 3 sessions a week for 3 months (Monday/Wednesday/Friday). Every session consisted of aerobic exercise protocol and warm-up, cooldown period. Patients aerobic loading capacity was calculated before the every session using by Karvonen formula as submaximal loading.

研究类型

介入性

注册 (实际的)

88

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

      • Istanbul、火鸡
        • Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

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

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Persons who were diagnosed with DM,
  2. Aged between 18 and 65 years,
  3. Patients who completed the three-month exercise program.

Exclusion Criteria:

  1. Had chronic drug (antidiabetic and antilipidemic) adjustments for 3 months at the beginning and during the exercise program,
  2. Participated in an exercise program before,
  3. Had a health condition other than DM associated with glucose metabolism.

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Exercise
Submaximal aerobic exercise protocol
The aerobic exercise protocol was performed 3 times a week for 3 months on the treadmill. Loading periods were performed according to the heart rate maximum using the Karvonen formula (%60-80 Heart rate maximum)

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
"Change" is being assessed for HbA1c
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month
"Change" is being assessed Total Cholesterol
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month
"Change" is being assessed for LDL
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month
"Change" is being assessed for HDL
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month
"Change" is being assessed for Blood Glucose
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month
"Change" is being assessed for Post prandial glucose
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month
"Change" is being assessed for Triglyceride
大体时间:Baseline and end of the 3rd month
Blood parameters
Baseline and end of the 3rd month

次要结果测量

结果测量
措施说明
大体时间
"Change" is being assessed for Blood Pressure
大体时间:Baseline and end of the 3rd month
Sistolic and Diastolic Pressure
Baseline and end of the 3rd month
"Change" is being assessed for Fat Mass (kg)
大体时间:Baseline and end of the 3rd month
Evaluation with bio-empedans device (TANITA)
Baseline and end of the 3rd month
"Change" is being assessed for Muscle Mass (kg)
大体时间:Baseline and end of the 3rd month
Evaluation with bio-empedans device (TANITA)
Baseline and end of the 3rd month
"Change" is being assessed for BMI
大体时间:Baseline and end of the 3rd month
Evaluation with bio-empedans device (TANITA)
Baseline and end of the 3rd month

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。

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1月2日

初级完成 (实际的)

2018年4月5日

研究完成 (实际的)

2019年12月10日

研究注册日期

首次提交

2020年3月19日

首先提交符合 QC 标准的

2020年3月20日

首次发布 (实际的)

2020年3月23日

研究记录更新

最后更新发布 (实际的)

2020年3月23日

上次提交的符合 QC 标准的更新

2020年3月20日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Aerobic exercise的临床试验

3
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