Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136013
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-07-26
Brief Title:
Exercise Timing and the Circadian Clock in Individuals With Type 2 Diabetes and Those at Risk
Sponsor:
Faculdade de Motricidade Humana
Organization:
Faculdade de Motricidade Humana
Study Overview
Official Title:
Another Look to Exercise Prescription Exercise Timing and the Circadian Clock in Individuals With Type 2 Diabetes and Those at Risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
EX-TIMING
Brief Summary:
Many investigations have been done to determine the exercise that can elicit the greatest benefits on glycemic control and metabolic health with findings suggesting that incorporation of higher intensity and longer duration of exercise prescribed may eliminate much of the non-response observed following exercise training Even with the incorporation of higher intensity exercise into interventions aimed at improving glycemic control in individuals with type 2 diabetes mellitus T2DM the investigators and others continue to have mixed results with not all individuals with T2DM obtaining benefits in insulin sensitivity and glycemic control to a given exercise training program
Many of the metabolic processes involved in glucose homeostasis such as insulin production and sensitivity undergo daily circadian rhythms controlled by cellular clock machinery located both centrally and peripherally ie skeletal muscle However in adults with T2DM these diurnal rhythms are impaired with reduced insulin sensitivity in the morning which is thought to contribute to the fasting hyperglycemia ie dawn phenomenon observed in these individuals Exercise may be a non-photic cue that can amplify or alter these metabolic rhythms It has been suggested that skeletal muscle metabolic inflexibility in metabolic disorders such as overweightobesity and T2DM is associated with reduced mitochondrial fatty acid oxidative capacity It has been demonstrated that exercise can increase mitochondrial oxidative capacity by remodeling mitochondrial morphology and dynamics It is unknown if potential differences in metabolic flexibility can be found in response to exercise at different times of the day
Most of the experimental evidence originates from animal models with only 3 studies performed in humans with T2DM which displayed conflicting results
To overcome the shortcomings in the literature the main objective of this research project is to assess the effects of performing exercise at different times of the day on glycemic control and related outcomes on the inter-individual response variability in glycemic control and related metabolic health parameters in two distinct populations 1 individuals with T2DM on the most common mono-hyperglycemic drug therapy ie metformin and 2 age-matched sedentary overweightobese individuals where glycemic control is known to deteriorate hence increasing the risk of developing insulin resistance and T2DM
Many of the metabolic processes involved in glucose homeostasis such as insulin production and sensitivity undergo daily circadian rhythms controlled by cellular clock machinery located both centrally and peripherally ie skeletal muscle However in adults with T2DM these diurnal rhythms are impaired with reduced insulin sensitivity in the morning which is thought to contribute to the fasting hyperglycemia ie dawn phenomenon observed in these individuals Exercise may be a non-photic cue that can amplify or alter these metabolic rhythms It has been suggested that skeletal muscle metabolic inflexibility in metabolic disorders such as overweightobesity and T2DM is associated with reduced mitochondrial fatty acid oxidative capacity It has been demonstrated that exercise can increase mitochondrial oxidative capacity by remodeling mitochondrial morphology and dynamics It is unknown if potential differences in metabolic flexibility can be found in response to exercise at different times of the day
Most of the experimental evidence originates from animal models with only 3 studies performed in humans with T2DM which displayed conflicting results
To overcome the shortcomings in the literature the main objective of this research project is to assess the effects of performing exercise at different times of the day on glycemic control and related outcomes on the inter-individual response variability in glycemic control and related metabolic health parameters in two distinct populations 1 individuals with T2DM on the most common mono-hyperglycemic drug therapy ie metformin and 2 age-matched sedentary overweightobese individuals where glycemic control is known to deteriorate hence increasing the risk of developing insulin resistance and T2DM
Detailed Description:
To detect a predicted mean difference in 24-hour area under the curve AUC continuous glucose measure CGM-based glucose of 10 mmolL with a within patient standard deviation SD of 085 mmolL 24 considering a type I error of 5 a power of 80 and a 30 dropout rate the investigators calculated a required sample size of 17 individuals for each group making a total sample of 34 individuals Group 1 T2DM Group 2 age-matched overweightobese
Participants will be recruited through flyers and posters in pharmacies health centers and supermarkets ads via national radios and television programs and the database of the Portuguese Association for the Protection of Diabetics APDP
To improve exercise adherence the following strategies will be implemented
Inform that participation in the study is completely voluntary and that all data will be confidential
Inform people that they will be able to do physical exercise guided by professionals for free
Inform that they will have individual follow-up by a personal trainer
Inform that they will carry out several analyzes and exams free of charge that will contribute to the control of their health status
Inform that they will be able to control their blood glucose levels and prevent or delay the complications of diabetes
Inform that they will learn appropriate physical exercises to better control diabetes Group 1 prevent diabetes Group 2 and improve overall health both Group 1 and 2 All study measurements will be collected at the Faculty of Human Kinetics University of Lisbon Body composition cardiopulmonary exercise test CPET blood collection metabolic flexibility dietary records and 24-hr CGM recording will be done at baseline as well as at the end of each 2-week intervention block Physical activity assessment will be performed at baseline and during each 2-week washout period The evaluations inherent to the project at baseline and at the end of each 2-week intervention block will take place on two different days
Participants will be recruited through flyers and posters in pharmacies health centers and supermarkets ads via national radios and television programs and the database of the Portuguese Association for the Protection of Diabetics APDP
To improve exercise adherence the following strategies will be implemented
Inform that participation in the study is completely voluntary and that all data will be confidential
Inform people that they will be able to do physical exercise guided by professionals for free
Inform that they will have individual follow-up by a personal trainer
Inform that they will carry out several analyzes and exams free of charge that will contribute to the control of their health status
Inform that they will be able to control their blood glucose levels and prevent or delay the complications of diabetes
Inform that they will learn appropriate physical exercises to better control diabetes Group 1 prevent diabetes Group 2 and improve overall health both Group 1 and 2 All study measurements will be collected at the Faculty of Human Kinetics University of Lisbon Body composition cardiopulmonary exercise test CPET blood collection metabolic flexibility dietary records and 24-hr CGM recording will be done at baseline as well as at the end of each 2-week intervention block Physical activity assessment will be performed at baseline and during each 2-week washout period The evaluations inherent to the project at baseline and at the end of each 2-week intervention block will take place on two different days
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