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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Exercise, Type-2 Diabetes Mellitus treatment, Body Composition, Blood Samples, Blood Pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

Submaximal aerobic exercise protocol

Outcomes

Primary Outcome Measures

"Change" is being assessed for HbA1c
Blood parameters
"Change" is being assessed Total Cholesterol
Blood parameters
"Change" is being assessed for LDL
Blood parameters
"Change" is being assessed for HDL
Blood parameters
"Change" is being assessed for Blood Glucose
Blood parameters
"Change" is being assessed for Post prandial glucose
Blood parameters
"Change" is being assessed for Triglyceride
Blood parameters

Secondary Outcome Measures

"Change" is being assessed for Blood Pressure
Sistolic and Diastolic Pressure
"Change" is being assessed for Fat Mass (kg)
Evaluation with bio-empedans device (TANITA)
"Change" is being assessed for Muscle Mass (kg)
Evaluation with bio-empedans device (TANITA)
"Change" is being assessed for BMI
Evaluation with bio-empedans device (TANITA)

Full Information

First Posted
March 19, 2020
Last Updated
March 20, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04318184
Brief Title
Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
Official Title
First Exercise Reports of Diabetes Centre: Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Exercise, Type-2 Diabetes Mellitus treatment, Body Composition, Blood Samples, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Submaximal aerobic exercise protocol
Intervention Type
Procedure
Intervention Name(s)
Aerobic exercise
Intervention Description
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 Measure Information:
Title
"Change" is being assessed for HbA1c
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed Total Cholesterol
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for LDL
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for HDL
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for Blood Glucose
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for Post prandial glucose
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for Triglyceride
Description
Blood parameters
Time Frame
Baseline and end of the 3rd month
Secondary Outcome Measure Information:
Title
"Change" is being assessed for Blood Pressure
Description
Sistolic and Diastolic Pressure
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for Fat Mass (kg)
Description
Evaluation with bio-empedans device (TANITA)
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for Muscle Mass (kg)
Description
Evaluation with bio-empedans device (TANITA)
Time Frame
Baseline and end of the 3rd month
Title
"Change" is being assessed for BMI
Description
Evaluation with bio-empedans device (TANITA)
Time Frame
Baseline and end of the 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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