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| ID | Type | Description | Link |
|---|---|---|---|
| 0358 | Other Grant/Funding Number | Research Council Faroe Islands |
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| Name | Class |
|---|---|
| National Hospital of the Faroe Islands | OTHER_GOV |
| University of Copenhagen | OTHER |
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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.
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
The primary hypothesis is that hybrid training (football) combining endurance, high-intensity interval, and resistance training improves general health status, blood glucose regulation, and muscle metabolism, as well as well-being in patients with T2DM. An exploratory hypothesis is that these changes occur irrespective of GLP-1 receptor agonist and SGLT-2 inhibitor treatment.
Methods
Men and women aged 40-70 diagnosed with T2DM within the last 10 years will be invited. Individuals with severe micro- or macrovascular complications and lactating or pregnant women will be excluded, as further detailed in the full protocol. Extraction from the electronic patient records indicates that approximately 800 individuals meet the criteria.
The study will be designed as a randomized control trial with small-sided football playing as the intervention. In the randomization, there will be stratification based on age (≥55 yrs/<55 yrs), gender (male/female) and whether the individuals are undergoing treatment with a GLP-1 receptor agonist or not (treatment/non-treatment). Patients will go through a test battery before (pre-tests) they are randomized into either a football group (FG) or a control group (CG) who will receive standard treatment. After the intervention, participants will undergo the same test battery (post-tests) for evaluation.
Test battery: blood pressure, blood parameters such as HbA1c, plasma glucose, C-peptide, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides, as well as systemic markers of inflammation, bone turnover markers, and urine albumin-to-creatinine ratio test. Body composition will be assessed by dual-energy X-ray absorptiometry (DXA) scans of body fat content, lean body mass, and bone mineralization. The patients will perform a Peak oxygen uptake test on a cycling ergometer as well as a Yo-Yo Intermittent Endurance test level 1 (Yo-Yo IE1) to determine physical fitness. To exclude severe peripheral neuropathy, vibration sensation in the feet will be measured using a biothesiometer along with the pre-tests.
To assess the 24-hour glucose profile, all participants in FG and CG will be provided with a blinded Continuous Glucose Monitoring system (CGM) with two sensors, each designed to last for 14 days. These sensors will be worn consecutively during the initial and final 14 days of the intervention period.
Finally, muscle biopsies will be obtained from a random subset of participants allocated to the FG (10 males and 10 females treated with GLP-1 and 10 males and 10 females not treated with GLP-1) in order to assess the potential impact of GLP-1 on training-induced adaptations in skeletal muscle.
Intervention
The FG group will train in small-sided football games for 60 minutes minimum three times per week for 14 weeks. Training will be intensified from walking football to small-sided game football (3v3-7v7) after two weeks, as described by Krustrup and Krustrup. Trained coaches will be responsible for the training sessions.
Perspective
Additional knowledge about the impact of hybrid training (football), combining endurance, high-intensity interval, and resistance training, on general health status, blood glucose regulation, muscle metabolism, and well-being in patients with T2DM, could form the basis for new recommendations in the treatment of this patient group. Furthermore, there is a need for a comprehensive understanding regarding the impact of hybrid training combined with GLP-1 receptor agonists and SGLT-2 inhibitor treatment in patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Active Comparator | Patients in the exercise group will engage in supervised soccer training 3 times a week for 14 weeks. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Behavioral | Exercise training will be performed as supervised small sided soccer games (3v3 to 7v7) 3 times a week for 14 weeks. Each session will last ~1 hour. Patients allocated to soccer training will undergo a ramp-up phase consisting of walking soccer training during weeks 1 and 2, after which normal soccer training will be applied from weeks 3 to 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Lean mass (kg) | Lean mass will be measured using Dual-energy X-ray absorptiometry (DXA) scans | Change from baseline to end-of-intervention (14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose (mmol/L) | Fasting plasma glucose will be measured from blood samples in a fasting state | Change from baseline to end-of-intervention (14 weeks) |
| Peak oxygen uptake (mL/min) |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic markers of inflammation (fg/mL) | Interferon gamma (fg/mL), tumor necrosis factor alpha (fg/mL) and interleukins 1beta, 2, 6, 8, 10 (fg/mL) will be measured from blood samples | Change from baseline to end-of-intervention (14 weeks) |
| White blood cell count (×10^9/L) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Faroe Islands | Tórshavn | 110 | Faroe Islands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24903461 | Background | Andersen TR, Schmidt JF, Thomassen M, Hornstrup T, Frandsen U, Randers MB, Hansen PR, Krustrup P, Bangsbo J. A preliminary study: effects of football training on glucose control, body composition, and performance in men with type 2 diabetes. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:43-56. doi: 10.1111/sms.12259. Epub 2014 Jun 5. | |
| 27697647 |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The participants are randomized in a 60:40 ratio to 1) exercise training or 2) control, using a stratified randomization approach. Stratification will be based on gender (male/female), age (≥55 years vs. <55 years), and GLP-1 agonist use (yes/no) to ensure that the distribution of gender, age, and GLP-1 agonist use is balanced across the two groups.
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The above-mentioned are masked with regards to exercise and control (non-exercise)
Statistical analysis of primary outcome will be blinded to the assessor.
|
Peak oxygen uptake will be measured on a bicycle ergometer
| Change from baseline to end-of-intervention (14 weeks) |
| Glycosylated hemoglobin A1c (HbA1c) (mmol/mol) | HbA1c will be measured from blood samples in a fasting state | Change from baseline to end-of-intervention (14 weeks) |
| C-peptide (nmol/L) | C-peptide will be measured from blood samples in a fasting state | Change from baseline to end-of-intervention (14 weeks) |
| 24h glycemic variability | Measured using continuous glucose monitors (CGM) during weeks 1 and 2 and weeks 13 and 14 | Change from baseline to end-of-intervention (14 weeks) |
| Body fat percentage (%) | Body fat percentage will be measured using Dual-energy X-ray absorptiometry (DXA) scans | Change from baseline to end-of-intervention (14 weeks) |
| Body fat mass (kg) | Body fat mass will be measured using Dual-energy X-ray absorptiometry (DXA) scans | Change from baseline to end-of-intervention (14 weeks) |
| Body weight (kg) | Body weight will be measured to the nearest 0.1 kg. in a fasting state without shoes and wearing light clothes. | Change from baseline to end-of-intervention (14 weeks) |
| Waist and hip circumference (cm) | Waist and hip circumference will be measured in duplicate after gentle expiration. | Change from baseline to end-of-intervention (14 weeks) |
| Blood pressure (mmHg) | Systolic- and diastolic blood pressure will be measured in duplicate from the non-dominant arm with a digital blood pressure monitor in sitting position after at least 5 min of rest. | Change from baseline to end-of-intervention (14 weeks) |
| Resting heart rate (bpm) | Resting heart rate will be measured in duplicate from the non-dominant arm with a digital blood pressure monitor in sitting position after at least 5 min of rest. | Change from baseline to end-of-intervention (14 weeks) |
| Lipid profile (mmol/L) | Total cholesterol (mmol/L), low-density lipoprotein-cholesterol (mmol/L), high-density lipoprotein cholesterol (mmol/l) and triglycerides (mmol/l) will be measured from blood samples in a fasting state. | Change from baseline to end-of-intervention (14 weeks) |
| Lipoprotein (a) (nmol/L) | Lipoprotein (a) will be measured from blood samples in a fasting state | Change from baseline to end-of-intervention (14 weeks) |
| Apolipoprotein B (nmol/L) | Apolipoprotein B will be measured from blood samples in a fasting state | Change from baseline to end-of-intervention (14 weeks) |
| World Health Organization Quality of Life - BREF instrument (scale score 0-100) | Quality of life will be evaluated with a Faroese version of the World Health Organization Quality of Life - BREF instrument (WHOQOL-BREF), which ranges from 1-5 for individual items and 0-100 for the overall domain scores with higher scores reflecting a higher quality of life. | Change from baseline to end-of-intervention (14 weeks) |
| Warwick-Edinburgh Mental Well-being Scale (scale score 14-70) | Mental well-being will be evaluated with a Faroese version of the Warwick-Edinburgh Mental Well-Being Scale, which is a 14-item scale covering subjective well-being and psychological functioning. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The minimum scale score is 14 and the maximum is 70. A high score indicates good mental well-being whereas a low score indicates poor mental well-being | Change from baseline to end-of-intervention (14 weeks) |
| Cardiorespiratory fitness (m) | Cardiorespiratory fitness will be evaluated using the Yo-Yo intermittent endurance test level 1. | Change from baseline to end-of-intervention (14 weeks) |
| Jump and balance | Countermovement jump and balance (bilateral quiet stand for 30 seconds with eyes open and one attempt with eyes closed as well as single leg stand for 15 seconds with hands on the hips and one foot raised) will be evaulated using the VALD Forcedeck force plates. | Change from baseline to end-of-intervention (14 weeks) |
| C-terminal telopeptide of type 1 collagen (ng/ml) | C-terminal telopeptide of type 1 collagen will be measured from blood samples. | Change from baseline to end-of-intervention (14 weeks) |
| Procollagen type 1 N propeptide (ng/ml) | Procollagen type 1 N propeptide will be measured from blood samples. | Change from baseline to end-of-intervention (14 weeks) |
| Osteocalcin (ng/ml) | Osteocalcin will be measured from blood samples | Change from baseline to end-of-intervention (14 weeks) |
| Bone mineral density (g/cm2) | Bone mineral density will be measured using Dual-energy X-ray absorptiometry (DXA) scans | Change from baseline to end-of-intervention (14 weeks) |
| Bone mineral content (g) | Bone mineral content will be measured using Dual-energy X-ray absorptiometry (DXA) scans | Change from baseline to end-of-intervention (14 weeks) |
| Skeletal muscle mitochondrial oxidative capacity (µmol/g/min) | Skeletal muscle oxidative capacity will be evaluated as maximal 3-hydroxy-acetylCoa-dehydrogenase and citrate synthase activity (µmol/g/min) | Change from baseline to end-of-intervention (14 weeks) |
| Skeletal muscle glucose transport capacity | Skeletal muscle glucose transport capacity will be evaluated as GLUT-4 protein expression | Change from baseline to end-of-intervention (14 weeks) |
White blood cell count will be measured from blood samples |
| Change from baseline to end-of-intervention (14 weeks) |
| C-reactive protein (mg/L) | C-reactive protein will be measured from blood samples | Change from baseline to end-of-intervention (14 weeks) |
| skeletal muscle muscle capillarization | Skeletal muscle muscle capillarization will be evaluated from immunohistochemical staining of muscle biopsies | Change from baseline to end-of-intervention (14 weeks) |
| Myofibre cross-sectional area | Myofibre cross-sectional area will be evaluated from immunohistochemical staining of muscle biopsies | Change from baseline to end-of-intervention (14 weeks) |
| Skeletal muscle glycogen content (mmol kg-1 d.w.) | For the biochemical assessment of whole-muscle glycogen content, muscle tissue will be freeze-dried and dissected free of blood and connective tissue, and analyzed spectrophotometrically. | Change from baseline to end-of-intervention (14 weeks) |
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