Type2diabetesNCT06478173
Exercise Training and Type 2 Diabetes
A study testing Exercise training in people with Type2diabetes, run by University of the Faroe Islands at 1 site in Faroe Islands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFaroe Islands
- Study dates
- 1 Aug 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes within ten years of study recruitment
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Faroe Islands1 site
University of the Faroe Islands
Tórshavn, 110
About this study
Official title: The Effect of Complex Exercise Training on General Health Status in Patients with Type 2 Diabetes
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Type2diabetes
- Being tested
- Exercise training
- Keywords
- Type2diabetes, Exercise training, Health, Adaptation, physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Active comparator | Patients in the exercise group will engage in supervised soccer training 3 times a week for 14 weeks. Receives: Behavioral: Exercise training |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean mass (kg)
Lean mass will be measured using Dual-energy X-ray absorptiometry (DXA) scans
Measured: Change from baseline to end-of-intervention (14 weeks)
Secondary outcomes (25)
Fasting plasma glucose (mmol/L)
Fasting plasma glucose will be measured from blood samples in a fasting state
Measured: Change from baseline to end-of-intervention (14 weeks)
Peak oxygen uptake (mL/min)
Peak oxygen uptake will be measured on a bicycle ergometer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to end-of-intervention (14 weeks)
Osteocalcin (ng/ml)
Osteocalcin will be measured from blood samples
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Change from baseline to end-of-intervention (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Aug 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Faroe Islands
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital of the Faroe Islands, University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478173
- Sponsor's protocol ID
- 2024.12
- Other IDs
- 0358
- Status last verified
- Dec 2024
- First submitted
- 7 Jun 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24903461Balakumar P, Maung-U K, Jagadeesh G. Prevalence and prevention of cardiovascular disease and diabetes mellitus. Pharmacol Res. 2016 Nov;113(Pt A):600-609. doi: 10.1016/j.phrs.2016.09.040. Epub 2016 Sep 30.
PubMed 27697647Barbosa A, Brito J, Figueiredo P, Seabra A, Mendes R. Football can tackle type 2 diabetes: a systematic review of the health effects of recreational football practice in individuals with prediabetes and type 2 diabetes. Res Sports Med. 2021 May-Jun;29(3):303-321. doi: 10.1080/15438627.2020.1777417. Epub 2020 Jun 22.
PubMed 32567951Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
PubMed 29496507Connolly LJ, Nordsborg NB, Nyberg M, Weihe P, Krustrup P, Mohr M. Low-volume high-intensity swim training is superior to high-volume low-intensity training in relation to insulin sensitivity and glucose control in inactive middle-aged women. Eur J Appl Physiol. 2016 Oct;116(10):1889-97. doi: 10.1007/s00421-016-3441-8. Epub 2016 Jul 29.
PubMed 27473445GBD 2015 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1659-1724. doi: 10.1016/S0140-6736(16)31679-8.
PubMed 27733284Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, Pownall HJ, Johnson KC, Safford MM, Kitabchi AE, Pi-Sunyer FX, Wing RR, Bertoni AG; Look AHEAD Research Group. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012 Dec 19;308(23):2489-96. doi: 10.1001/jama.2012.67929.
PubMed 23288372Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637-646. doi: 10.1001/jama.2017.10169.
PubMed 28810024Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U; Lancet Physical Activity Series Working Group. Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet. 2012 Jul 21;380(9838):247-57. doi: 10.1016/S0140-6736(12)60646-1.
PubMed 22818937Krustrup P, Krustrup BR. Football is medicine: it is time for patients to play! Br J Sports Med. 2018 Nov;52(22):1412-1414. doi: 10.1136/bjsports-2018-099377. Epub 2018 Jun 9. No abstract available.
PubMed 29886433Krustrup P, Skoradal MB, Randers MB, Weihe P, Uth J, Mortensen J, Mohr M. Broad-spectrum health improvements with one year of soccer training in inactive mildly hypertensive middle-aged women. Scand J Med Sci Sports. 2017 Dec;27(12):1893-1901. doi: 10.1111/sms.12829. Epub 2017 Jan 25.
PubMed 28124381MacLeod SF, Terada T, Chahal BS, Boule NG. Exercise lowers postprandial glucose but not fasting glucose in type 2 diabetes: a meta-analysis of studies using continuous glucose monitoring. Diabetes Metab Res Rev. 2013 Nov;29(8):593-603. doi: 10.1002/dmrr.2461.
PubMed 24038928Milanovic Z, Pantelic S, Sporis G, Mohr M, Krustrup P. Health-Related Physical Fitness in Healthy Untrained Men: Effects on VO2max, Jump Performance and Flexibility of Soccer and Moderate-Intensity Continuous Running. PLoS One. 2015 Aug 25;10(8):e0135319. doi: 10.1371/journal.pone.0135319. eCollection 2015.
PubMed 26305880Mohr M, Lindenskov A, Holm PM, Nielsen HP, Mortensen J, Weihe P, Krustrup P. Football training improves cardiovascular health profile in sedentary, premenopausal hypertensive women. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:36-42. doi: 10.1111/sms.12278.
PubMed 24944131Noyes AM, Dua K, Devadoss R, Chhabra L. Cardiac adipose tissue and its relationship to diabetes mellitus and cardiovascular disease. World J Diabetes. 2014 Dec 15;5(6):868-76. doi: 10.4239/wjd.v5.i6.868.
PubMed 25512789
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complex Exercise Training on General Health Status in Patients with Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06478173
- Acronym / sponsor ID
- 2024.12
- Conditions
- Type2diabetes
- Keywords
- Type2diabetes, Exercise training, Health, Adaptation, physiological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of the Faroe IslandsUniversity, hospital or other
- Collaborators
- National Hospital of the Faroe Islands, University of Copenhagen
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Active comparator | Behavioral: Exercise trainingPatients in the exercise group will engage in supervised soccer training 3 times a week for 14 weeks. |
| 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with type 2 diabetes within ten years of study recruitment
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise 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. | Behavioural | Exercise training |
Primary outcome
Lean mass (kg)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Lean mass will be measured using Dual-energy X-ray absorptiometry (DXA) scans
25 secondary outcomes
Fasting plasma glucose (mmol/L)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Peak oxygen uptake (mL/min)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Glycosylated hemoglobin A1c (HbA1c) (mmol/mol)
Time frame: Change from baseline to end-of-intervention (14 weeks)
C-peptide (nmol/L)
Time frame: Change from baseline to end-of-intervention (14 weeks)
24h glycemic variability
Time frame: Change from baseline to end-of-intervention (14 weeks)
Body fat percentage (%)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Body fat mass (kg)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Body weight (kg)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Waist and hip circumference (cm)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Blood pressure (mmHg)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Resting heart rate (bpm)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Lipid profile (mmol/L)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Lipoprotein (a) (nmol/L)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Apolipoprotein B (nmol/L)
Time frame: Change from baseline to end-of-intervention (14 weeks)
World Health Organization Quality of Life - BREF instrument (scale score 0-100)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Warwick-Edinburgh Mental Well-being Scale (scale score 14-70)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Cardiorespiratory fitness (m)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Jump and balance
Time frame: Change from baseline to end-of-intervention (14 weeks)
C-terminal telopeptide of type 1 collagen (ng/ml)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Procollagen type 1 N propeptide (ng/ml)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Osteocalcin (ng/ml)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Bone mineral density (g/cm2)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Bone mineral content (g)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Skeletal muscle mitochondrial oxidative capacity (µmol/g/min)
Time frame: Change from baseline to end-of-intervention (14 weeks)
Skeletal muscle glucose transport capacity
Time frame: Change from baseline to end-of-intervention (14 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 24903461Andersen 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.
- Background: PubMed 27697647Balakumar P, Maung-U K, Jagadeesh G. Prevalence and prevention of cardiovascular disease and diabetes mellitus. Pharmacol Res. 2016 Nov;113(Pt A):600-609. doi: 10.1016/j.phrs.2016.09.040. Epub 2016 Sep 30.
- Background: PubMed 32567951Barbosa A, Brito J, Figueiredo P, Seabra A, Mendes R. Football can tackle type 2 diabetes: a systematic review of the health effects of recreational football practice in individuals with prediabetes and type 2 diabetes. Res Sports Med. 2021 May-Jun;29(3):303-321. doi: 10.1080/15438627.2020.1777417. Epub 2020 Jun 22.
- Background: PubMed 29496507Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
- Background: PubMed 27473445Connolly LJ, Nordsborg NB, Nyberg M, Weihe P, Krustrup P, Mohr M. Low-volume high-intensity swim training is superior to high-volume low-intensity training in relation to insulin sensitivity and glucose control in inactive middle-aged women. Eur J Appl Physiol. 2016 Oct;116(10):1889-97. doi: 10.1007/s00421-016-3441-8. Epub 2016 Jul 29.
- Background: PubMed 27733284GBD 2015 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1659-1724. doi: 10.1016/S0140-6736(16)31679-8.
- Background: PubMed 23288372Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, Pownall HJ, Johnson KC, Safford MM, Kitabchi AE, Pi-Sunyer FX, Wing RR, Bertoni AG; Look AHEAD Research Group. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012 Dec 19;308(23):2489-96. doi: 10.1001/jama.2012.67929.
- Background: PubMed 28810024Johansen MY, MacDonald CS, Hansen KB, Karstoft K, Christensen R, Pedersen M, Hansen LS, Zacho M, Wedell-Neergaard AS, Nielsen ST, Iepsen UW, Langberg H, Vaag AA, Pedersen BK, Ried-Larsen M. Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Aug 15;318(7):637-646. doi: 10.1001/jama.2017.10169.
- Background: PubMed 22818937Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U; Lancet Physical Activity Series Working Group. Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet. 2012 Jul 21;380(9838):247-57. doi: 10.1016/S0140-6736(12)60646-1.
- Background: PubMed 29886433Krustrup P, Krustrup BR. Football is medicine: it is time for patients to play! Br J Sports Med. 2018 Nov;52(22):1412-1414. doi: 10.1136/bjsports-2018-099377. Epub 2018 Jun 9. No abstract available.
- Background: PubMed 28124381Krustrup P, Skoradal MB, Randers MB, Weihe P, Uth J, Mortensen J, Mohr M. Broad-spectrum health improvements with one year of soccer training in inactive mildly hypertensive middle-aged women. Scand J Med Sci Sports. 2017 Dec;27(12):1893-1901. doi: 10.1111/sms.12829. Epub 2017 Jan 25.
- Background: PubMed 24038928MacLeod SF, Terada T, Chahal BS, Boule NG. Exercise lowers postprandial glucose but not fasting glucose in type 2 diabetes: a meta-analysis of studies using continuous glucose monitoring. Diabetes Metab Res Rev. 2013 Nov;29(8):593-603. doi: 10.1002/dmrr.2461.
- Individual participant dataSharing planned: No
Related trials for Type2diabetes
Enrolling by invitation
Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study
Type 2 Diabetes Mellitus, Type2diabetes
Recruiting
Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
Type2diabetes, Heart Failure
Recruiting
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
Pre-Gestational Diabetes, Type2diabetes
RecruitingPhase 4
SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes
Type2diabetes, PreDiabetes
RecruitingObservational study
Susceptibility to Infectious Diseases in Obesity
Obesity, Type2diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Type2diabetes, run by University of the Faroe Islands at 1 site in Faroe Islands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Faroe Islands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean mass (kg) (time frame: Change from baseline to end-of-intervention (14 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06478173, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.