Diabetes MellitusNCT05902546
Effect of HIIT Vs Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 DM
A study testing High intensity interval training and moderate intensity aerobic exercise in people with Diabetes Mellitus and Insulin Resistance, run by Badr University at 4 sites in Egypt.
Trial summary
Comparing between the efficacy of high intensity interval training and moderate intensity aerobic exercises on insulin resistance in type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Insulin Resistance
- What is being tested?
- High intensity interval training and moderate intensity aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesEgypt
- Study dates
- 7 Jan 2023to 30 Sep 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 Diabetes Mellitus Patients.
- Diagnosed for more than 1 years at the time of the study.
- Patients with fair control of blood glucose using hypoglycemic drugs
Who cannot join
- Type 1 (Insulin Dependant) Diabetes Mellitus patients.
- Patients with disability that can't perform exercises.
- Patient with known Cardiovascular diseases.
- Patients with kidney/liver diseases
Trial locations and contacts
4 sites in 1 country.
Egypt4 sites
Ahmed Maher Teaching Hospital
Cairo, 11662
Elamahaba Specialized Charity Polyclinics
Cairo, 11725
Trust Physical Therapy Center and Rehabilitation
Cairo, 11771
Badr University in Cairo, Faculty of Physical Therapy, Outpatient Clinic
Cairo, 11829
About this study
Official title: Effect of High Intensity Interval Training Versus Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 Diabetes
Comparing between the efficacy of high intensity interval training and moderate intensity aerobic exercises on insulin resistance in type 2 Diabetes Mellitus.
Read the detailed description
The study aims at differentiating between high intensity interval training and moderate intensity continuous aerobic exercise in terms of their effect of Insulin resistance in patients diagnosed with type 2 Diabetes Mellitus. All participants will have lab analysis for Serum Homa-IR prior to intervention and after 1 month of treatment.
- Conditions
- Diabetes Mellitus, Insulin Resistance
- Being tested
- High intensity interval training, moderate intensity aerobic exercise
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
Patients will receive interval training exercise of high intensity. This includes several rounds that alternate between several minutes of high intensity movements to significantly increase the heart rate to at least 80% of one's maximum heart rate, followed by short periods of rest
moderate intensity aerobic exerciseOther
Patients will receive moderate intensity continuous aerobic exercise (walking) for 40 minutes (preceded by 10 minutes warming up and followed by 5 minutes cooling down)
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training (group A) | Experimental | 30 Diabetic patients (Type 2 Diabetes Mellitus) will receive high intensity interval training Receives: Other: High intensity interval training |
| moderate intensity aerobic exercise (group B) | Experimental | 30 Diabetic patients (Type 2 Diabetes Mellitus) will receive moderate intensity aerobic exercise Receives: Other: moderate intensity aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance (Homa-IR)
Serum insulin resistance indicator (Homa-IR)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start7 Jan 2023
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Maher Teaching Hospital
- Responsible party
- Principal investigator, Mina Atef Georgui Elias, Badr University
- Investigators
- Mina AG Elias, Dr., Principal investigator, Dept of Internal Medicine & geriatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.Khaled M Mounir, Dr., Study chair, Dept of Cardiopulmonary & internal medicine rehab, Faculty of Physical Therapy, Galala Univ; Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902546
- Sponsor's protocol ID
- BUC-IACUC-230507-21
- Status last verified
- Oct 2023
- First submitted
- 3 Jun 2023
- Last updated
- 27 Oct 2023
- Results posted
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval Training Versus Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05902546
- Acronym / sponsor ID
- BUC-IACUC-230507-21
- Conditions
- Diabetes Mellitus, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Collaborators
- Ahmed Maher Teaching Hospital
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Jun 2023 (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.
Comparing between the efficacy of high intensity interval training and moderate intensity aerobic exercises on insulin resistance in type 2 Diabetes Mellitus.
Detailed description
The study aims at differentiating between high intensity interval training and moderate intensity continuous aerobic exercise in terms of their effect of Insulin resistance in patients diagnosed with type 2 Diabetes Mellitus. All participants will have lab analysis for Serum Homa-IR prior to intervention and after 1 month of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training (group A) | Experimental | Other: High intensity interval training30 Diabetic patients (Type 2 Diabetes Mellitus) will receive high intensity interval training |
| moderate intensity aerobic exercise (group B) | Experimental | Other: moderate intensity aerobic exercise30 Diabetic patients (Type 2 Diabetes Mellitus) will receive moderate intensity aerobic exercise |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes Mellitus Patients.
- Diagnosed for more than 1 years at the time of the study.
- Patients with fair control of blood glucose using hypoglycemic drugs
Key exclusion criteria (4 listed)
- Type 1 (Insulin Dependant) Diabetes Mellitus patients.
- Patients with disability that can't perform exercises.
- Patient with known Cardiovascular diseases.
- Patients with kidney/liver diseases
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 |
|---|---|---|
| High intensity interval trainingPatients will receive interval training exercise of high intensity. This includes several rounds that alternate between several minutes of high intensity movements to significantly increase the heart rate to at least 80% of one's maximum heart rate, followed by short periods of rest | Other | High intensity interval training (group A) |
| moderate intensity aerobic exercisePatients will receive moderate intensity continuous aerobic exercise (walking) for 40 minutes (preceded by 10 minutes warming up and followed by 5 minutes cooling down) | Other | moderate intensity aerobic exercise (group B) |
Primary outcome
Insulin Resistance (Homa-IR)
Time frame: 1 month
Serum insulin resistance indicator (Homa-IR)
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 27 Oct 2023.
- 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.
Mina AG Elias, Dr. principal investigator
Dept of Internal Medicine & geriatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
Khaled M Mounir, Dr. study chair
Dept of Cardiopulmonary & internal medicine rehab, Faculty of Physical Therapy, Galala Univ; Egypt.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training and moderate intensity aerobic exercise in people with Diabetes Mellitus and Insulin Resistance, run by Badr University at 4 sites in Egypt.
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 4 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt. 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?
Insulin Resistance (Homa-IR) (time frame: 1 month). 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 27 Oct 2023.