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

First Exercise Reports of Diabetes Centre: 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Procedure: Aerobic exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): April 5, 2018
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Body Composition; Blood Pressure; Blood Samples; Type-2 Diabetes Mellitus treatment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 17073117-050.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No