NCT05902546

Brief Summary

Comparing between the efficacy of high intensity interval training and moderate intensity aerobic exercises on insulin resistance in type 2 Diabetes Mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

June 3, 2023

Last Update Submit

October 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Insulin Resistance (Homa-IR)

    Serum insulin resistance indicator (Homa-IR)

    1 month

Study Arms (2)

High intensity interval training (group A)

EXPERIMENTAL

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

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

Other: moderate intensity aerobic exercise

Interventions

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

High intensity interval training (group A)

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)

moderate intensity aerobic exercise (group B)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ahmed Maher Teaching Hospital

Cairo, 11662, Egypt

Location

Elamahaba Specialized Charity Polyclinics

Cairo, 11725, Egypt

Location

Trust Physical Therapy Center and Rehabilitation

Cairo, 11771, Egypt

Location

Badr University in Cairo, Faculty of Physical Therapy, Outpatient Clinic

Cairo, 11829, Egypt

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mina AG Elias, Dr.

    Dept of Internal Medicine & geriatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

    PRINCIPAL INVESTIGATOR
  • Khaled M Mounir, Dr.

    Dept of Cardiopulmonary & internal medicine rehab, Faculty of Physical Therapy, Galala Univ; Egypt.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Internal Medicine & Geriatrics, Faculty of Physical Therapy, Badr University in Cairo.

Study Record Dates

First Submitted

June 3, 2023

First Posted

June 15, 2023

Study Start

January 7, 2023

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations