Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
126 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-01
Study Completion Date
2024-12-20
Brief Summary
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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: 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
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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.
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
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Type2diabetes
Keywords
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Type2diabetes
Exercise training
Health
Adaptation, physiological
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
OTHER
Blinding Strategy
TRIPLE
Caregivers
Investigators
Outcome Assessors
The above-mentioned are masked with regards to exercise and control (non-exercise)
Statistical analysis of primary outcome will be blinded to the assessor.
Statistical analysis of primary outcome will be blinded to the assessor.
Study Groups
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Exercise training
Patients in the exercise group will engage in supervised soccer training 3 times a week for 14 weeks.
Group Type
ACTIVE_COMPARATOR
Exercise training
Intervention Type
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.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Exercise training
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes within ten years of study recruitment
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Hospital of the Faroe Islands
OTHER_GOV
Sponsor Role
collaborator
University of Copenhagen
OTHER
Sponsor Role
collaborator
University of the Faroe Islands
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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University of the Faroe Islands
Tórshavn, , Faroe Islands
Site Status
Countries
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Faroe Islands
References
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Barbosa 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.
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Connolly 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.
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BACKGROUND
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Johansen 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.
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Reference Type
BACKGROUND
Krustrup 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.
Reference Type
BACKGROUND
Krustrup 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.
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BACKGROUND
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BACKGROUND
Milanovic 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.
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BACKGROUND
Mohr 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.
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Pedersen BK, Saltin B. Evidence for prescribing exercise as therapy in chronic disease. Scand J Med Sci Sports. 2006 Feb;16 Suppl 1:3-63. doi: 10.1111/j.1600-0838.2006.00520.x.
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Pedersen MT, Vorup J, Nistrup A, Wikman JM, Alstrom JM, Melcher PS, Pfister GU, Bangsbo J. Effect of team sports and resistance training on physical function, quality of life, and motivation in older adults. Scand J Med Sci Sports. 2017 Aug;27(8):852-864. doi: 10.1111/sms.12823. Epub 2017 Feb 1.
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Redmon JB, Bertoni AG, Connelly S, Feeney PA, Glasser SP, Glick H, Greenway F, Hesson LA, Lawlor MS, Montez M, Montgomery B; Look AHEAD Research Group. Effect of the look AHEAD study intervention on medication use and related cost to treat cardiovascular disease risk factors in individuals with type 2 diabetes. Diabetes Care. 2010 Jun;33(6):1153-8. doi: 10.2337/dc09-2090. Epub 2010 Mar 23.
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BACKGROUND
Ried-Larsen M, Christensen R, Hansen KB, Johansen MY, Pedersen M, Zacho M, Hansen LS, Kofoed K, Thomsen K, Jensen MS, Nielsen RO, MacDonald C, Langberg H, Vaag AA, Pedersen BK, Karstoft K. Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial. BMJ Open. 2015 Dec 9;5(12):e009764. doi: 10.1136/bmjopen-2015-009764.
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Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans. Endocrinol Metab (Seoul). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247.
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BACKGROUND
Skoradal MB, Helge EW, Jorgensen NR, Mortensen J, Weihe P, Krustrup P, Mohr M. Osteogenic impact of football training in 55- to 70-year-old women and men with prediabetes. Scand J Med Sci Sports. 2018 Aug;28 Suppl 1:52-60. doi: 10.1111/sms.13252. Epub 2018 Jul 26.
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BACKGROUND
Skoradal MB, Weihe P, Patursson P, Mortensen J, Connolly L, Krustrup P, Mohr M. Football training improves metabolic and cardiovascular health status in 55- to 70-year-old women and men with prediabetes. Scand J Med Sci Sports. 2018 Aug;28 Suppl 1:42-51. doi: 10.1111/sms.13081. Epub 2018 May 2.
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BACKGROUND
Veyhe AS, Andreassen J, Halling J, Grandjean P, Petersen MS, Weihe P. Prevalence of type 2 diabetes and prediabetes in the Faroe Islands. Diabetes Res Clin Pract. 2018 Jun;140:162-173. doi: 10.1016/j.diabres.2018.03.036. Epub 2018 Mar 27.
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BACKGROUND
Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
Reference Type
BACKGROUND
Other Identifiers
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0358
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024.12
Identifier Type: -
Identifier Source: org_study_id