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Completed

NCT Number: NCT04318184

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Procedure

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 23, 2020
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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