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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318184
Recruitment Status : Completed
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Marmara University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Procedure: Aerobic exercise Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First Exercise Reports of Diabetes Centre: Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
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)




Primary Outcome Measures :
  1. "Change" is being assessed for HbA1c [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters

  2. "Change" is being assessed Total Cholesterol [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters

  3. "Change" is being assessed for LDL [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters

  4. "Change" is being assessed for HDL [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters

  5. "Change" is being assessed for Blood Glucose [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters

  6. "Change" is being assessed for Post prandial glucose [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters

  7. "Change" is being assessed for Triglyceride [ Time Frame: Baseline and end of the 3rd month ]
    Blood parameters


Secondary Outcome Measures :
  1. "Change" is being assessed for Blood Pressure [ Time Frame: Baseline and end of the 3rd month ]
    Sistolic and Diastolic Pressure

  2. "Change" is being assessed for Fat Mass (kg) [ Time Frame: Baseline and end of the 3rd month ]
    Evaluation with bio-empedans device (TANITA)

  3. "Change" is being assessed for Muscle Mass (kg) [ Time Frame: Baseline and end of the 3rd month ]
    Evaluation with bio-empedans device (TANITA)

  4. "Change" is being assessed for BMI [ Time Frame: Baseline and end of the 3rd month ]
    Evaluation with bio-empedans device (TANITA)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318184


Locations
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Turkey
Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
Istanbul, Turkey
Sponsors and Collaborators
Marmara University
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT04318184    
Other Study ID Numbers: 17073117-050.06
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
Exercise
Type-2 Diabetes Mellitus treatment
Body Composition
Blood Samples
Blood Pressure
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases