the Effect of Fasted Versus Post-meal HIIT on Glycemic Control in Men With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Percentage of glycated hemoglobin
Study Overview
Brief Summary
Background: Recently, high intensity interval training (HIIT) has emerged as a promising regimen for the management of type 2 diabetic subjects. However, there is no consensus on the best time for HIIT regarding nutritional status.
Purpose: to investigate the effect of fasted versus postprandial HIIT training on glycemic control in men with type 2 Diabetes Mellitus.
Methods: This study enrolled 123 subjects suffering from type 2 diabetes mellitus with ages between 40 and 60 years. Subjects were divided into 4 groups, The post-breakfast, post-lunch and post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The HIIT program involved 3 sessions weekly for 12 weeks. Glycated hemoglobin, fasting blood glucose, fasting insulin, insulin sensitivity, body composition, and blood lipid values were evaluated pre- and post-intervention.
Detailed Description
METHODS Study Design This study was performed as a randomized, controlled trial and included four groups. The study procedures were carried out in the department of physical therapy and health rehabilitation, Prince Sattam Bin Abdulaziz University.
Ethical consideration The study protocol was approved by the Standing Committee of Bioethics Research in Prince Sattam bin Abdulaziz University, Saudi Arabia (ID: SCBR-352/2024). The study was conducted in line with the principles of the Declaration of Helsinki. All study participants have signed a written informed consent form. The aim, procedures and potential risks of the study were explained to the study population.
Participants:
A total of 160 men with T2DM were recruited from nearby hospitals and clinics to participate in this study and 123 completed the study follow-up. A licensed physician performed the preliminary evaluation for all participants. Participants were instructed to maintain their medications, their usual dietary habits and usual physical activity throughout the study period.
Only men diagnosed with T2DM, aged 40-60 years and inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months) were included in this study. Subjects treated with exogenous insulin, and those with cardiovascular or musculoskeletal diseases limiting participation in HIIT were excluded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Only men diagnosed with T2DM,
- •Aged 40-60 years
- •Inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months)
Exclusion Criteria
- •Subjects treated with exogenous insulin
- •Cardiovascular diseases limiting participation in HIIT
- •Musculoskeletal diseases limiting participation in HIIT
Arms & Interventions
Fasted-group
practiced HIIT prebreakfast in the fasted state (8-12 h fasting)
Intervention: high intensity interval training (Other)
Post-breakfast
practiced HIIT 2 hours after breakfast
Intervention: high intensity interval training (Other)
Post-lunch
practiced HIIT 2 hours after lunch
Intervention: high intensity interval training (Other)
Post-dinner
practiced HIIT 2 hours after dinner
Intervention: high intensity interval training (Other)
Outcomes
Primary Outcomes
Percentage of glycated hemoglobin
Time Frame: 3 months
Percentage of glycated hemoglobin (HbA1c) levels are measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan).
Secondary Outcomes
- Body weight in kg(3 months)
- Body Mass Index (BMI) in kg/m2(3 months)
- Waist Circumference in cm(3 months)
- Concentration of Fasting plasma insulin in μU/ml(3 months)
- Concentration of Fasting blood glucose in mg/dl(3 months)
- concentration of total blood cholesterol in mg/dl(3 months)
- concentration of total blood triglyceride in mg/dl(3 months)
Investigators
Ahmad Saied Mohammad
Principal Investigator
Prince Sattam Bin Abdulaziz University