Diabetes Mellitus, Type 2xnxNCT04181853
The Effect of Aerobic Exercise on Genetic Molecules
A study testing exercise in people with Diabetes Mellitus, Type 2 and Aerobic Exercise, run by Pamukkale University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Aerobic Exercise, Genetic Response
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Feb 2020to 30 May 2022
- 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinica diagnosis of type 2 Diabetes mellitus less than 10 years and more than 1 year.
- must have appropriate medical therapy and diet.
- must not be treated with insulin.
- must be exercising less than 210 minutes/ week
Who cannot join
- prominent cardiovascular disease
- coronary artery disease
- moderate to severe valvular disease
- atrial fibrillation
- untreated hypertension
- congenital heart disease
Show all 15Show fewer
- retinopathy
- neuropathy
- macro albuminuria
- cerebrovascular disease
- ejection fraction less than 40
- body mass index greater than 35.
- prominent ischemic changes in EKG at rest or during exercise.
- cigarette or alcohol addiction
- on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Pamukkale University
Denizli, 20100
Pamukkale University
Denizli, 21600
About this study
Official title: The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules in patients with type 2 diabetes mellitus.
Read the detailed description
Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with blood tests to measure genetic molecules related with metabolism.
- Being tested
- exercise
- Keywords
- Type 2 diabetes mellitus, exercise, aerobic
- 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.
exerciseOther
aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval exercise | Active comparator | Participants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital. Receives: Other: exercise |
| Moderate intensity continuous exercise | Active comparator | Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital. Receives: Other: exercise |
| No Intervention: Control group | No intervention | Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic molecules
HbA1c level in the serum
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start5 Feb 2020
- Primary completion30 May 2022
- Study completion30 May 2022
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has 3 arms
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GULIN FINDIKOGLU, Pamukkale University
- Investigators
- Gulin Findikoglu, Assoc Prof, Principal investigator, Pamukkale University,Medical Faculty, PMR Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181853
- Sponsor's protocol ID
- 60116787-020/83243
- Acronym
- xnx
- Status last verified
- Sep 2022
- First submitted
- 23 Nov 2019
- Last updated
- 30 Sep 2022
- 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise on Genetic Molecules Related With Metabolism
- ClinicalTrials.gov ID
- NCT04181853
- Acronym / sponsor ID
- xnx / 60116787-020/83243
- Keywords
- Type 2 diabetes mellitus, exercise, aerobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 2 Dec 2019 (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.
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules in patients with type 2 diabetes mellitus.
Detailed description
Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with blood tests to measure genetic molecules related with metabolism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study has 3 arms
| Arm | Type | Receives |
|---|---|---|
| High intensity interval exercise | Active comparator | Other: exerciseParticipants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital. |
| Moderate intensity continuous exercise | Active comparator | Other: exerciseParticipants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital. |
| No Intervention: Control group | No intervention | –Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinica diagnosis of type 2 Diabetes mellitus less than 10 years and more than 1 year.
- must have appropriate medical therapy and diet.
- must not be treated with insulin.
- must be exercising less than 210 minutes/ week
Key exclusion criteria (15 listed)
- prominent cardiovascular disease
- coronary artery disease
- moderate to severe valvular disease
- atrial fibrillation
- untreated hypertension
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 |
|---|---|---|
| exerciseaerobic exercise | Other | High intensity interval exercise, Moderate intensity continuous exercise |
Primary outcome
genetic molecules
Time frame: 12 weeks
HbA1c level in the serum
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 30 Sep 2022.
- 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.
Gulin Findikoglu, Assoc Prof principal investigator
Pamukkale University,Medical Faculty, PMR Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Diabetes Mellitus, Type 2 and Aerobic Exercise, run by Pamukkale University at 2 sites 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 4 inclusion and 15 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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
genetic molecules (time frame: 12 weeks). 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 30 Sep 2022.