Type 2 DiabetesNCT04315519
Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus
A study testing Exercise in people with Type 2 Diabetes, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Sep 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having Type 2 Diabetes
- Not have been recruited any exercise programme for 6 months
- Volunteering to participate in the study
Who cannot join
- Nephropathy
- Retinopathy
- Have had myocardial infarction at least 6 months ago
- Stable or unstable angina pectoris
- The presence of peripheral artery disease
- Resting blood pressure above 160/100 mmHg
- Body mass index over 35 kg / m2
- History of deep vein thrombosis, pulmonary embolism or stroke
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Effect of Blood Flow Restricted Aerobic Exercise on Cardiorespiratory Fitness and Blood Glucose in Type 2 Diabetes Mellitus
Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.
Read the detailed description
The aim of this study is to show, whether the effect of low-intensity aerobic exercise training combined with blood flow restriction is similar on both glycemic and cardiorespiratory status compared to moderate-intensity continuous aerobic exercise, in individuals with "type 2 diabetes mellitus" .
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise
- Keywords
- Blood Flow Restricted Exercise, Type 2 Diabetes, Aerobic Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Blood Flow Restricted Aerobic (BFRA) | Experimental | Low intensity Aerobic exercise with Blood Flow Restriction Receives: Other: Exercise |
| Moderate Aerobic Exercise (MAE) | Experimental | moderate intensity aerobic exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests
Measured: up to 12 months
HbA1c
Glycated hemoglobin, This data will be collected from teh individulas during routine test
Measured: up to 12 months
Blood Glucose in Oral glucose Tolerance Test
Blood Glucose in Oral glucose Tolerance Test, this data will be collected from the individuals during routine tests.
Measured: Up to 12 months
Cardiorespiratory Fitness
Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer.
Measured: Up to 12 months
Secondary outcomes (3)
The Strength of Quadriceps Muscle
The Strength of Quadriceps Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
Measured: Up to 12 months
Fat Free Mass
Fat Free Mass will be calculated by bioimpedance analysis, this data will be collected with all individulas to see the changes with the muscle mass, the test will be The test will be carried out with a 4-channel test device, both hand and foot, to eveluate changes segmentally.
Measured: Up to 12 months
The Strength of Hamstring Muscle
The Strength of Hamstring Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif ŞAHİN, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315519
- Sponsor's protocol ID
- 26
- Status last verified
- Mar 2020
- First submitted
- 27 Jan 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Blood Flow Restricted Aerobic Exercise on Cardiorespiratory Fitness and Blood Glucose in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04315519
- Acronym / sponsor ID
- 26
- Conditions
- Type 2 Diabetes
- Keywords
- Blood Flow Restricted Exercise, Type 2 Diabetes, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 19 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.
Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.
Detailed description
The aim of this study is to show, whether the effect of low-intensity aerobic exercise training combined with blood flow restriction is similar on both glycemic and cardiorespiratory status compared to moderate-intensity continuous aerobic exercise, in individuals with "type 2 diabetes mellitus" .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restricted Aerobic (BFRA) | Experimental | Other: ExerciseLow intensity Aerobic exercise with Blood Flow Restriction |
| Moderate Aerobic Exercise (MAE) | Experimental | Other: Exercisemoderate intensity aerobic exercise |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having Type 2 Diabetes
- Not have been recruited any exercise programme for 6 months
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- Nephropathy
- Retinopathy
- Have had myocardial infarction at least 6 months ago
- Stable or unstable angina pectoris
- The presence of peripheral artery disease
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 | Blood Flow Restricted Aerobic (BFRA), Moderate Aerobic Exercise (MAE) |
Primary outcome
Blood Glucose
Time frame: up to 12 months
Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests
HbA1c
Time frame: up to 12 months
Glycated hemoglobin, This data will be collected from teh individulas during routine test
Blood Glucose in Oral glucose Tolerance Test
Time frame: Up to 12 months
Blood Glucose in Oral glucose Tolerance Test, this data will be collected from the individuals during routine tests.
Cardiorespiratory Fitness
Time frame: Up to 12 months
Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer.
3 secondary outcomes
The Strength of Quadriceps Muscle
Time frame: Up to 12 months
Fat Free Mass
Time frame: Up to 12 months
The Strength of Hamstring Muscle
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Type 2 Diabetes, run by Recep Tayyip Erdogan University Training and Research Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif SAHIN (+90 (464) 344 20 45, fztelifsahin61@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: up to 12 months). The study lists 4 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 19 Mar 2020.