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Effect of HIIT Vs Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 DM

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High intensity interval training
moderate intensity aerobic exercise
Sponsored by
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ahmed Maher Teaching HospitalRecruiting
  • Elamahaba Specialized Charity PolyclinicsRecruiting
  • Trust Physical Therapy Center and RehabilitationRecruiting
  • Badr University in Cairo, Faculty of Physical Therapy, Outpatient ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High intensity interval training (group A)

moderate intensity aerobic exercise (group B)

Arm Description

30 Diabetic patients (Type 2 Diabetes Mellitus) will receive high intensity interval training

30 Diabetic patients (Type 2 Diabetes Mellitus) will receive moderate intensity aerobic exercise

Outcomes

Primary Outcome Measures

Insulin Resistance (Homa-IR)
Serum insulin resistance indicator (Homa-IR)

Secondary Outcome Measures

Full Information

First Posted
June 3, 2023
Last Updated
June 3, 2023
Sponsor
Badr University
Collaborators
Ahmed Maher Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05902546
Brief Title
Effect of HIIT Vs Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 DM
Official Title
Effect of High Intensity Interval Training Versus Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
Collaborators
Ahmed Maher Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training (group A)
Arm Type
Experimental
Arm Description
30 Diabetic patients (Type 2 Diabetes Mellitus) will receive high intensity interval training
Arm Title
moderate intensity aerobic exercise (group B)
Arm Type
Experimental
Arm Description
30 Diabetic patients (Type 2 Diabetes Mellitus) will receive moderate intensity aerobic exercise
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
moderate intensity aerobic exercise
Intervention Description
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)
Primary Outcome Measure Information:
Title
Insulin Resistance (Homa-IR)
Description
Serum insulin resistance indicator (Homa-IR)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina AG Elias, Dr.
Phone
+201227227266
Email
mina.elias@buc.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled M Mounir, Dr.
Phone
+201222229777
Email
khaled.khalil@gu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Organizational Affiliation
Dept of Internal Medicine & geriatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khaled M Mounir, Dr.
Organizational Affiliation
Dept of Cardiopulmonary & internal medicine rehab, Faculty of Physical Therapy, Galala Univ; Egypt.
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Maher Teaching Hospital
City
Cairo
ZIP/Postal Code
11662
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Phone
+201227227266
Email
mina.elias@buc.edu.eg
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
First Name & Middle Initial & Last Name & Degree
Khaled M Mounir, Dr.
Facility Name
Elamahaba Specialized Charity Polyclinics
City
Cairo
ZIP/Postal Code
11725
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Phone
+201227227266
Email
mina.elias@buc.edu/eg
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Facility Name
Trust Physical Therapy Center and Rehabilitation
City
Cairo
ZIP/Postal Code
11771
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Phone
+201227227266
Email
mina.elias@buc.edu.eg
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Facility Name
Badr University in Cairo, Faculty of Physical Therapy, Outpatient Clinic
City
Cairo
ZIP/Postal Code
11829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.
Phone
+201227227266
Email
mina.elias@buc.edu.eg
First Name & Middle Initial & Last Name & Degree
Mina AG Elias, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of HIIT Vs Moderate Intensity Aerobic Exercise on Insulin Resistance in Type 2 DM

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