- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05902546
Effect of HIIT Vs Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 DM
October 25, 2023 updated by: Mina Atef Georgui Elias, Badr University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11662
- Ahmed Maher Teaching Hospital
-
Cairo, Egypt, 11725
- Elamahaba Specialized Charity Polyclinics
-
Cairo, Egypt, 11771
- Trust Physical Therapy Center and Rehabilitation
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Cairo, Egypt, 11829
- Badr University in Cairo, Faculty of Physical Therapy, Outpatient Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High intensity interval training (group A)
30 Diabetic patients (Type 2 Diabetes Mellitus) will receive high intensity interval training
|
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
|
|
Experimental: moderate intensity aerobic exercise (group B)
30 Diabetic patients (Type 2 Diabetes Mellitus) will receive moderate intensity aerobic exercise
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin Resistance (Homa-IR)
Time Frame: 1 month
|
Serum insulin resistance indicator (Homa-IR)
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mina AG Elias, Dr., Dept of Internal Medicine & geriatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
- Study Chair: Khaled M Mounir, Dr., Dept of Cardiopulmonary & internal medicine rehab, Faculty of Physical Therapy, Galala Univ; Egypt.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2023
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
June 3, 2023
First Submitted That Met QC Criteria
June 3, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUC-IACUC-230507-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.