Diabetes Mellitus, Type 2NCT04318184
Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
A study testing Aerobic exercise in people with Diabetes Mellitus, Type 2, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Aerobic exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons who were diagnosed with DM,
- Aged between 18 and 65 years,
- Patients who completed the three-month exercise program.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Aerobic exercise
- Keywords
- Exercise, Type-2 Diabetes Mellitus treatment, Body Composition, Blood Samples, Blood Pressure
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Submaximal aerobic exercise protocol Receives: Procedure: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change" is being assessed for HbA1c
Blood parameters
Measured: Baseline and end of the 3rd month
"Change" is being assessed Total Cholesterol
Blood parameters
Measured: Baseline and end of the 3rd month
"Change" is being assessed for LDL
Blood parameters
Measured: Baseline and end of the 3rd month
"Change" is being assessed for HDL
Blood parameters
Measured: Baseline and end of the 3rd month
"Change" is being assessed for Blood Glucose
Blood parameters
Measured: Baseline and end of the 3rd month
"Change" is being assessed for Post prandial glucose
Blood parameters
Measured: Baseline and end of the 3rd month
"Change" is being assessed for Triglyceride
Blood parameters
Measured: Baseline and end of the 3rd month
Secondary outcomes (4)
"Change" is being assessed for Blood Pressure
Sistolic and Diastolic Pressure
Measured: Baseline and end of the 3rd month
"Change" is being assessed for Fat Mass (kg)
Evaluation with bio-empedans device (TANITA)
Measured: Baseline and end of the 3rd month
"Change" is being assessed for Muscle Mass (kg)
Evaluation with bio-empedans device (TANITA)
Measured: Baseline and end of the 3rd month
"Change" is being assessed for BMI
Evaluation with bio-empedans device (TANITA)
Measured: Baseline and end of the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start2 Jan 2018
- Primary completion5 Apr 2018
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318184
- Sponsor's protocol ID
- 17073117-050.06
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Exercise Reports of Diabetes Centre: Effects of Exercise on Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04318184
- Acronym / sponsor ID
- 17073117-050.06
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Type-2 Diabetes Mellitus treatment, Body Composition, Blood Samples, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Procedure: Aerobic exerciseSubmaximal aerobic exercise protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons who were diagnosed with DM,
- Aged between 18 and 65 years,
- Patients who completed the three-month exercise program.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseThe 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) | Procedure or surgery | Exercise |
Primary outcome
"Change" is being assessed for HbA1c
Time frame: Baseline and end of the 3rd month
Blood parameters
"Change" is being assessed Total Cholesterol
Time frame: Baseline and end of the 3rd month
Blood parameters
"Change" is being assessed for LDL
Time frame: Baseline and end of the 3rd month
Blood parameters
"Change" is being assessed for HDL
Time frame: Baseline and end of the 3rd month
Blood parameters
"Change" is being assessed for Blood Glucose
Time frame: Baseline and end of the 3rd month
Blood parameters
"Change" is being assessed for Post prandial glucose
Time frame: Baseline and end of the 3rd month
Blood parameters
"Change" is being assessed for Triglyceride
Time frame: Baseline and end of the 3rd month
Blood parameters
4 secondary outcomes
"Change" is being assessed for Blood Pressure
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Fat Mass (kg)
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for Muscle Mass (kg)
Time frame: Baseline and end of the 3rd month
"Change" is being assessed for BMI
Time frame: Baseline and end of the 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Diabetes Mellitus, Type 2, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Change" is being assessed for HbA1c (time frame: Baseline and end of the 3rd month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.