Exercise Training and Type 2 Diabetes

NCT06478173 | Completed DMC

• 2 other identifiers: 2024.120358
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type2diabetes

Keywords

Type2diabetes; Exercise training; Health; Adaptation, physiological

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (25)

• Fasting plasma glucose (mmol/L)

  Change from baseline to end-of-intervention (14 weeks)

• Peak oxygen uptake (mL/min)

  Change from baseline to end-of-intervention (14 weeks)

• Glycosylated hemoglobin A1c (HbA1c) (mmol/mol)

  Change from baseline to end-of-intervention (14 weeks)

• C-peptide (nmol/L)

  Change from baseline to end-of-intervention (14 weeks)

• 24h glycemic variability

  Change from baseline to end-of-intervention (14 weeks)

Other Outcomes (6)

• Systemic markers of inflammation (fg/mL)

  Change from baseline to end-of-intervention (14 weeks)

• White blood cell count (×10^9/L)

  Change from baseline to end-of-intervention (14 weeks)

• C-reactive protein (mg/L)

  Change from baseline to end-of-intervention (14 weeks)

Study Arms (2)

Exercise training

ACTIVE COMPARATOR

Patients in the exercise group will engage in supervised soccer training 3 times a week for 14 weeks.

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.

Interventions

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.

Exercise training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes within ten years of study recruitment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Faroe Islands: lead
• National Hospital of the Faroe Islands: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

University of the Faroe Islands

Tórshavn, 110, Faroe Islands

Location

Related Publications (26)

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  PMID: 29886433 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.

  PMID: 28124381 BACKGROUND

• MacLeod 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.

  PMID: 24038928 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.

  PMID: 26305880 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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• 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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• 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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• 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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• 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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• 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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  PMID: 29219149 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The above-mentioned are masked with regards to exercise and control (non-exercise) Statistical analysis of primary outcome will be blinded to the assessor.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 27, 2024
• Study Start: August 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FA (1)