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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons who were diagnosed with DM, Aged between 18 and 65 years, Patients who completed the three-month exercise program. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Submaximal aerobic exercise protocol | Procedure: Aerobic exercise<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed for HbA1c | Blood parameters | Baseline and end of the 3rd month | 
| Change is being assessed Total Cholesterol | Blood parameters | Baseline and end of the 3rd month | 
| Change is being assessed for LDL | Blood parameters | Baseline and end of the 3rd month | 
| Change is being assessed for HDL | Blood parameters | Baseline and end of the 3rd month | 
| Change is being assessed for Blood Glucose | Blood parameters | Baseline and end of the 3rd month | 
| Change is being assessed for Post prandial glucose | Blood parameters | Baseline and end of the 3rd month | 
| Change is being assessed for Triglyceride | Blood parameters | Baseline and end of the 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed for Blood Pressure | Sistolic and Diastolic Pressure | Baseline and end of the 3rd month | 
| Change is being assessed for Fat Mass (kg) | Evaluation with bio-empedans device (TANITA) | Baseline and end of the 3rd month | 
| Change is being assessed for Muscle Mass (kg) | Evaluation with bio-empedans device (TANITA) | Baseline and end of the 3rd month | 
| Change is being assessed for BMI | Evaluation with bio-empedans device (TANITA) | Baseline and end of the 3rd month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Type-2 Diabetes Mellitus treatment, Body Composition, Blood Samples, Blood Pressure