The Effect of Complex Exercise Training on General Health Status in Patients with Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Lean mass (kg)
研究概览
简要总结
Objective: This study investigates the effects of hybrid training in the form of small-sided football games on health status, blood glucose regulation, muscle metabolism, and well-being in patients with type 2 diabetes mellitus (T2DM), with additional focus on the impact of concurrent treatment with Glucagon-Like Peptide-1 receptor agonists and Sodium-Glucose Co-Transporter-2 inhibitors.
Background: T2DM prevalence has surged globally, characterized by insulin resistance, abnormal insulin secretion, and elevated blood glucose levels, significantly increasing cardiovascular disease risk. Physical activity is known to reduce visceral fat, improve glycaemic control, and lower cardiovascular mortality. However, the interaction between hybrid training and T2DM medication effects remains underexplored.
Methods: A randomized controlled trial will be conducted with men and women aged 40-70 diagnosed with T2DM within the last 10 years. Exclusion criteria include severe micro- or macrovascular complications and pregnancy. Participants (n=800) will be invited and enrolled participants will be randomized in a 60/40 ratio into a football group (FG) or control group (CG), using a stratified randomization approach. Stratification will be based on age, gender and GLP-1 agonist treatment. The FG will engage in 60-minute small-sided football sessions three times per week for 14 weeks. Both groups will undergo pre- and post-intervention assessments, including blood pressure, blood parameters, body composition via dual-energy X-ray absorptiometry scans, physical fitness (Peak oxygen uptake and Yo-Yo Intermittent Endurance Test Level 1), and 24-hour glucose profiling using Continuous Glucose Monitoring systems. Muscle biopsies will be collected from a subset of participants.
Conclusion: This study aims to provide insights into the benefits of hybrid training for T2DM patients, potentially informing new treatment guidelines that integrate exercise and pharmacotherapy to optimize health outcomes.
详细描述
Background
In recent years, there's been heightened awareness of chronic diseases like type 2 diabetes mellitus (T2DM) and their global impact. T2DM has surged dramatically, with cases quadrupling in the last 30 years. The International Diabetes Federation estimates 451 million cases globally, with projections indicating a rise to 629 million by 2045. In high-income countries, T2DM prevalence peaks in older age groups, and a study from the Faroe Islands shows the same tendency. T2DM is characterized by insulin resistance (often associated with visceral obesity), abnormal insulin secretion, and elevated blood glucose levels. It significantly increases the risk of cardiovascular disease, which is the leading cause of death among T2DM patients.
Studies on T2DM patients demonstrate that 2-3 months of regular aerobic training leads to a significant reduction in visceral fat, ranging from 27% to 45% in men and women. Additionally, physical exercise improves glycemic control, with postprandial blood glucose lowered after aerobic, resistance, or combined training. Combination training, including aerobic and resistance exercises or team sports, is recommended for T2DM patients, offering optimal benefits. High-intensity interval training has shown efficiency in blood glucose regulation. Intensive lifestyle interventions in T2DM patients can markedly improve regulation and increase the likelihood of partial remission compared to general diabetes support programs. Small-sided football game studies demonstrate beneficial effects on fasting plasma glucose and complication markers. Physical fitness protects against all-cause mortality and cardiovascular death. Even low-volume physical activity is associated with a significant reduction in the relative risk of noncommunicable diseases. Recent studies suggest that complex training modes like team sports can provide broad-spectrum health effects, even with volumes lower than WHO recommendations.
Standard treatment for T2DM typically includes dietary guidance and advice on a healthy lifestyle. Medical therapy often includes metformin tablets, a Glucagon-Like Peptide-1 (GLP-1) receptor agonist, and/or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, and insulin. A large portion of T2DM patients on the Faroe Islands are undergoing GLP-1 receptor agonist or SGLT-2 inhibitor treatment. Studies have shown that these medications are highly effective in improving glucose levels and promoting weight loss. The weight loss mainly involves a decrease in fat mass. However, a review has revealed that the reduction in lean body mass accounts for 20% to 50% of the total weight lost, aligning with weight loss observed with dietary changes and bariatric surgery. Therefore, it is also important to investigate to what extent the positive impact of hybrid training is influenced by GLP-1 receptor agonist and SGLT-2 inhibitor treatment.
Hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The above-mentioned are masked with regards to exercise and control (non-exercise)
Statistical analysis of primary outcome will be blinded to the assessor.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes within ten years of study recruitment
排除标准
- •Diabetic retinopathy (expect mild non-proliferative retinopathy or early proliferative retinopathy
- •Macro-albuminuria (urine albumin-creatinine ratio ≥ 300 mg/g)
- •Nepropathy (plasma creatinine ≥ 130 μM)
- •Diabetic neuropathy (except mild affected vibratory testing (<50 V)
- •History of ischemic heart disease
- •History or signs of arterial insufficiency
- •Steroid treatment within 3 months of baseline examination
- •Thyroid disease
- •Inability or contraindication to increased levels of physical activity
- •Anaemia (haemoglobin < 7.3 mmol/L (women) and 8.3 mmol/L (men)
- •Signs of kidney disease
- •Pregnancy or breast feeding
研究组 & 干预措施
Exercise training
Patients in the exercise group will engage in supervised soccer training 3 times a week for 14 weeks.
干预措施: Exercise training (Behavioral)
Control
Patients in the control group will receive standard treatment and be instructed to maintain habitual activity levels at the same level as before enrollment in the study.
结局指标
主要结局
Lean mass (kg)
时间窗: Change from baseline to end-of-intervention (14 weeks)
Lean mass will be measured using Dual-energy X-ray absorptiometry (DXA) scans
次要结局
- Apolipoprotein B (nmol/L)(Change from baseline to end-of-intervention (14 weeks))
- World Health Organization Quality of Life - BREF instrument (scale score 0-100)(Change from baseline to end-of-intervention (14 weeks))
- Fasting plasma glucose (mmol/L)(Change from baseline to end-of-intervention (14 weeks))
- Peak oxygen uptake (mL/min)(Change from baseline to end-of-intervention (14 weeks))
- Glycosylated hemoglobin A1c (HbA1c) (mmol/mol)(Change from baseline to end-of-intervention (14 weeks))
- C-peptide (nmol/L)(Change from baseline to end-of-intervention (14 weeks))
- 24h glycemic variability(Change from baseline to end-of-intervention (14 weeks))
- Body fat percentage (%)(Change from baseline to end-of-intervention (14 weeks))
- Body fat mass (kg)(Change from baseline to end-of-intervention (14 weeks))
- Body weight (kg)(Change from baseline to end-of-intervention (14 weeks))
- Waist and hip circumference (cm)(Change from baseline to end-of-intervention (14 weeks))
- Blood pressure (mmHg)(Change from baseline to end-of-intervention (14 weeks))
- Resting heart rate (bpm)(Change from baseline to end-of-intervention (14 weeks))
- Lipid profile (mmol/L)(Change from baseline to end-of-intervention (14 weeks))
- Lipoprotein (a) (nmol/L)(Change from baseline to end-of-intervention (14 weeks))
- Warwick-Edinburgh Mental Well-being Scale (scale score 14-70)(Change from baseline to end-of-intervention (14 weeks))
- Cardiorespiratory fitness (m)(Change from baseline to end-of-intervention (14 weeks))
- Jump and balance(Change from baseline to end-of-intervention (14 weeks))
- C-terminal telopeptide of type 1 collagen (ng/ml)(Change from baseline to end-of-intervention (14 weeks))
- Procollagen type 1 N propeptide (ng/ml)(Change from baseline to end-of-intervention (14 weeks))
- Osteocalcin (ng/ml)(Change from baseline to end-of-intervention (14 weeks))
- Bone mineral density (g/cm2)(Change from baseline to end-of-intervention (14 weeks))
- Bone mineral content (g)(Change from baseline to end-of-intervention (14 weeks))
- Skeletal muscle mitochondrial oxidative capacity (µmol/g/min)(Change from baseline to end-of-intervention (14 weeks))
- Skeletal muscle glucose transport capacity(Change from baseline to end-of-intervention (14 weeks))