An interventional study of Aerobic exercise in Diabetes Mellitus, Type 2, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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.
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 88 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Submaximal aerobic exercise protocol
Procedure: Aerobic exercise
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)
"Change" is being assessed for HbA1c
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed Total Cholesterol
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for LDL
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for HDL
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Blood Glucose
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Post prandial glucose
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Triglyceride
Blood parameters
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Blood Pressure
Sistolic and Diastolic Pressure
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Fat Mass (kg)
Evaluation with bio-empedans device (TANITA)
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Muscle Mass (kg)
Evaluation with bio-empedans device (TANITA)
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for BMI
Evaluation with bio-empedans device (TANITA)
Time frame: Baseline and end of the 3rd month
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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