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临床试验/NCT04318184
NCT04318184已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
"Change" is being assessed for HbA1c

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

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

入选标准

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

排除标准

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

结局指标

主要结局

"Change" is being assessed for HbA1c

时间窗: Baseline and end of the 3rd month

Blood parameters

"Change" is being assessed for LDL

时间窗: Baseline and end of the 3rd month

Blood parameters

"Change" is being assessed for Triglyceride

时间窗: Baseline and end of the 3rd month

Blood parameters

"Change" is being assessed Total Cholesterol

时间窗: Baseline and end of the 3rd month

Blood parameters

"Change" is being assessed for HDL

时间窗: Baseline and end of the 3rd month

Blood parameters

"Change" is being assessed for Blood Glucose

时间窗: Baseline and end of the 3rd month

Blood parameters

"Change" is being assessed for Post prandial glucose

时间窗: Baseline and end of the 3rd month

Blood parameters

次要结局

  • "Change" is being assessed for Blood Pressure(Baseline and end of the 3rd month)
  • "Change" is being assessed for Fat Mass (kg)(Baseline and end of the 3rd month)
  • "Change" is being assessed for Muscle Mass (kg)(Baseline and end of the 3rd month)
  • "Change" is being assessed for BMI(Baseline and end of the 3rd month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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