the Effect of Fasted Versus Post-meal HIIT on Glycemic Control in Men With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Percentage of glycated hemoglobin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Subjects treated with exogenous insulin
- •Cardiovascular diseases limiting participation in HIIT
- •Musculoskeletal diseases limiting participation in HIIT
结局指标
主要结局
Percentage of glycated hemoglobin
时间窗: 3 months
Percentage of glycated hemoglobin (HbA1c) levels are measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan).
次要结局
- 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)
研究者
Ahmad Saied Mohammad
Principal Investigator
Prince Sattam Bin Abdulaziz University