Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562842
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Exercise Gut Microbiota and Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Regular Exercise on Gut Microbiota Composition in Individuals With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ex-GM-T2D
Brief Summary:
This randomized parallel controlled study will investigate the effect of regular exercise on GM composition inflammatory status and insulin sensitivity in the progression from normal glucose tolerance NGT to prediabetes pre-D to type 2 diabetes T2D Following baseline assessment of glucose tolerance the participants will be randomly assigned to either a 12-week thrice-weekly exercise training program followed by 4 weeks of detraining or will remain sedentary for the 16-week intervention Thus the six study groups will be 1 NGT group NGT NGT individuals - no exercise 2 NGT exercise group NGTEx NGT individuals that will participate in training and detraining 3 pre-D group pre-D pre-D individuals - no exercise 4 pre-D exercise group Pre-DEx pre-D individuals that will participate in training and detraining 5 T2D group T2D T2D individuals - no exercise and 6 T2D exercise group T2DEx T2D individuals that will participate in training and detraining Assessment of physiological measures anthropometric characteristics body composition glucose tolerance insulin sensitivity complete blood count lipidemic profile GM composition inflammatory status oxidative stress and muscle performance will be conducted before and following 12 weeks of the exercise training intervention and following 4 weeks of detraining for all participants
Detailed Description:
Type 2 diabetes is a global metabolic epidemic and a major global health threat In 2021 537 million adults aged 20-79 years worldwide had diabetes T2D is related with life threatening microvascular and macrovascular health complications that contribute tremendously to the burden of mortality and disability worldwide T2D is defined by fasting hyperglycemia which is largely secondary to inadequate action of insulin T2D is usually preceded by a state of intermediate hyperglycemia or Pre-D which is characterized by impaired fasting glucose IFG impaired glucose tolerance IGT or both and greatly increases the risk for T2D In T2D although insulin levels are normal or high tissues such as liver skeletal muscle and adipose tissue become resistant to insulin resulting in high levels of blood glucose T2D is associated with a systemic inflammatory response which seems to be an independent risk factor for the development of T2D Additionally individuals with T2D tend to have a more oxidative internal environment than healthy subjects Hyperglycemia-induced oxidative stress has been found to affect the insulin signaling cascade and decrease GLUT4 gene transcription and also alter mitochondrial activity T2D pathophysiology has also been associated with GM composition Dysbiosis of GM is suggested to have a central role in the pathogenesis of insulin resistance and T2D through several mechanisms
The important role of regular exercise for the prevention and treatment of T2D has been established Most benefits of exercise on T2D management and prevention are realized through the adaptations to skeletal muscle which in turn induce acute and chronic improvements in insulin action Exercise also exerts anti-inflammatory effects Emerged evidence suggests that exercise may also favorably affect T2D by improving GM composition The most promising effect of regular exercise is the alteration of GM towards a healthier microbial composition by producing a more diverse GM decreasing pathogenic bacterial communities and increasing SCFAs-producing bacteria However the impact of exercise on the GM structure and function of T2D individuals is poorly understood as only a limited number of studies exist in this area so far
According to a preliminary power analysis a probability error of 005 and a statistical power of 80 a sample size of 8-10 participantsgroup was considered appropriate to detect statistically meaningful changes between trials Thus 60 middle-aged individuals will be assessed for eligibility to participate in the study The study will be conducted in a parallel randomized controlled design The participants will be primarily informed of the study procedures as well as the benefits and possible risks and they will also sign an informed consent form for participation in the study All eligible individuals will provide blood samples for the determination of fasting blood glucose glycosylated hemoglobin HbA1c and fasting plasma insulin and will take an oral glucose tolerance test OGTT to determine their glycemic profile according to which they will be characterized as normal glucose tolerance NGT individuals or pre-diabetes pre-D individuals or type 2 diabetes T2D individuals Physical activity levels will also be assessed through the International Physical Activity Questionnaire IPAQ Afterwards the participants of each glucose tolerance stage will be randomly assigned to either the 12 weeks of regular combined aerobic and resistance exercise according to the guidelines for pre-D and T2D individuals or remain sedentary for 12 weeks Thus six intervention groups will be as follows i NGT group NGTG NGT individuals - no exercise ii NGT exercise group NGTGEx NGT individuals that will participate in training and detraining iii pre-D group pre-DG pre-D individuals - no exercise iv pre-D exercise group Pre-DGEx pre-D individuals that will participate in training and detraining v T2D group T2DG T2D individuals - no exercise and vi T2D exercise group T2DGEx T2D individuals that will participate in training and detraining Randomization of the conditions will be done by a software generating random integers available on the internet Randomorg
Baseline measurements will take place at the Laboratory of Biochemistry Physiology and Nutrition of Exercise SmArT Lab Department of Physical Education and Sports University of Thessaly physiological measures resting heart rate resting systolic and diastolic blood pressure resting metabolic rate anthropometric characteristics body height body mass body mass index body composition amount of body fat lean body mass fat mass bone density muscle performance aerobic capacity VO2max isokinetic strength of the lower extremities isometric concentric and eccentric torque of the knee extensors and knee flexors handgrip strength muscle power countermovement jump Additionally the participants will provide feces for the determination of GM composition and GM metabolites short chain fatty acids SCFAs as well as blood samples for the determination of complete blood count CBC systemic inflammation tumor necrosis factor alpha TNF-α interleukin 6 IL-6 C-reactive protein CRP zonulin lipopolysaccharides-binding protein LBP blood redox status total antioxidant capacity TAC catalase CAT protein carbonyls PC reduced glutathione GSH oxidized glutathione GSSG GSHGSSG ratio malondialdehyde MDA uric acid bilirubin and lipid profile total cholesterol CHO-T low density lipoprotein LDL high density lipoprotein HDL triglycerides TG In addition the participants will record their diet via a 7-days recall before their participation in the first experimental condition and dietary data will be analyzed All of the above measurements will be repeated following the 12-weeks of exercise intervention as well as following the 4-weeks of detraining period The participants that will be allocated into the regular exercise except for VO2max they will further undergo estimation of maximal strength of the main muscle groups for the determination of intensity of each participants exercise program aerobic capacity and muscle strength determination will also be repeated after four weeks of the regular exercise for the necessary intensity adjustments of the exercise program
The important role of regular exercise for the prevention and treatment of T2D has been established Most benefits of exercise on T2D management and prevention are realized through the adaptations to skeletal muscle which in turn induce acute and chronic improvements in insulin action Exercise also exerts anti-inflammatory effects Emerged evidence suggests that exercise may also favorably affect T2D by improving GM composition The most promising effect of regular exercise is the alteration of GM towards a healthier microbial composition by producing a more diverse GM decreasing pathogenic bacterial communities and increasing SCFAs-producing bacteria However the impact of exercise on the GM structure and function of T2D individuals is poorly understood as only a limited number of studies exist in this area so far
According to a preliminary power analysis a probability error of 005 and a statistical power of 80 a sample size of 8-10 participantsgroup was considered appropriate to detect statistically meaningful changes between trials Thus 60 middle-aged individuals will be assessed for eligibility to participate in the study The study will be conducted in a parallel randomized controlled design The participants will be primarily informed of the study procedures as well as the benefits and possible risks and they will also sign an informed consent form for participation in the study All eligible individuals will provide blood samples for the determination of fasting blood glucose glycosylated hemoglobin HbA1c and fasting plasma insulin and will take an oral glucose tolerance test OGTT to determine their glycemic profile according to which they will be characterized as normal glucose tolerance NGT individuals or pre-diabetes pre-D individuals or type 2 diabetes T2D individuals Physical activity levels will also be assessed through the International Physical Activity Questionnaire IPAQ Afterwards the participants of each glucose tolerance stage will be randomly assigned to either the 12 weeks of regular combined aerobic and resistance exercise according to the guidelines for pre-D and T2D individuals or remain sedentary for 12 weeks Thus six intervention groups will be as follows i NGT group NGTG NGT individuals - no exercise ii NGT exercise group NGTGEx NGT individuals that will participate in training and detraining iii pre-D group pre-DG pre-D individuals - no exercise iv pre-D exercise group Pre-DGEx pre-D individuals that will participate in training and detraining v T2D group T2DG T2D individuals - no exercise and vi T2D exercise group T2DGEx T2D individuals that will participate in training and detraining Randomization of the conditions will be done by a software generating random integers available on the internet Randomorg
Baseline measurements will take place at the Laboratory of Biochemistry Physiology and Nutrition of Exercise SmArT Lab Department of Physical Education and Sports University of Thessaly physiological measures resting heart rate resting systolic and diastolic blood pressure resting metabolic rate anthropometric characteristics body height body mass body mass index body composition amount of body fat lean body mass fat mass bone density muscle performance aerobic capacity VO2max isokinetic strength of the lower extremities isometric concentric and eccentric torque of the knee extensors and knee flexors handgrip strength muscle power countermovement jump Additionally the participants will provide feces for the determination of GM composition and GM metabolites short chain fatty acids SCFAs as well as blood samples for the determination of complete blood count CBC systemic inflammation tumor necrosis factor alpha TNF-α interleukin 6 IL-6 C-reactive protein CRP zonulin lipopolysaccharides-binding protein LBP blood redox status total antioxidant capacity TAC catalase CAT protein carbonyls PC reduced glutathione GSH oxidized glutathione GSSG GSHGSSG ratio malondialdehyde MDA uric acid bilirubin and lipid profile total cholesterol CHO-T low density lipoprotein LDL high density lipoprotein HDL triglycerides TG In addition the participants will record their diet via a 7-days recall before their participation in the first experimental condition and dietary data will be analyzed All of the above measurements will be repeated following the 12-weeks of exercise intervention as well as following the 4-weeks of detraining period The participants that will be allocated into the regular exercise except for VO2max they will further undergo estimation of maximal strength of the main muscle groups for the determination of intensity of each participants exercise program aerobic capacity and muscle strength determination will also be repeated after four weeks of the regular exercise for the necessary intensity adjustments of the exercise program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None