- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630025
Concurrent Exercise Training (T2D)
The Impact of Morning Versus Evening Concurrent High-Intensity Interval Training and Resistance Training on Glycemic Control in in Men With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
The goal of this clinical trial is to investigate the influence of morning versus evening concurrent training consisting of high-intensity interval training and resistance training on glycemic control in men with type 2 diabetes mellitus. The main questions it aims to answer are:
• Which time is best for concurrent exercise training in diabetic patients, morning or evening? Researchers will compare morning versus evening concurrent training consisting of HIIT and RT on glycemic control in men with type 2 diabetes mellitus.
Participants will:
- Perform concurrent training consisting of high-intensity interval training and resistance training for 12 weeks
- Visit the clinic before and after the 12-week experimental period for checkups and tests
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- men aged 40-60 years with a diagnosis of T2D
- HbA1c levels between 7.0% and 9.0%
- treatment with oral hypoglycemic agents for at least 6 months
- a BMI <30 kg/m²
- a physically inactive
Exclusion Criteria:
- current insulin therapy
- a cardiovascular event within the previous 6 months
- cardiovascular, respiratory or musculoskeletal conditions that could limit participation in exercise training
- body weight instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Morning concurrent training (amCT)
will perform combined HIIT and RT between 06:00 and 09:00
|
Morning concurrent high-intensity interval training and resistance training
|
|
Experimental: Evening concurrent training (pmCT)
will perform combined HIIT and RT between 16:00 and 19:00
|
evening concurrent high-intensity interval training and resistance training between 16:00 and 19:00
|
|
No Intervention: The control group (CON)
no exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
glycemic control
Time Frame: baseline and at 12 weeks.
|
HbA1c
|
baseline and at 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lipid profile
Time Frame: baseline and at 12 weeks
|
total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides
|
baseline and at 12 weeks
|
|
cardiorespiratory fitness
Time Frame: at baseline and at 12 weeks
|
VO2peak
|
at baseline and at 12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT 2026
- 2025/03/33413 (Other Grant/Funding Number: Prince Sattam bin Abdulaziz University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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