Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478173
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-07
Brief Title:
Exercise Training and Type 2 Diabetes
Sponsor:
University of the Faroe Islands
Organization:
University of the Faroe Islands
Study Overview
Official Title:
The Effect of Complex Exercise Training on General Health Status in Patients With Type 2 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n800 will be invited and enrolled participants will be randomized in a 6040 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 n800 will be invited and enrolled participants will be randomized in a 6040 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 theres 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 andor 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 yrs55 yrs gender malefemale and whether the individuals are undergoing treatment with a GLP-1 receptor agonist or not treatmentnon-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 theres 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 andor 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 yrs55 yrs gender malefemale and whether the individuals are undergoing treatment with a GLP-1 receptor agonist or not treatmentnon-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0358 | OTHER_GRANT | None | None |