Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656377
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Optimization of Exercise Protocol for Prediabetic Population in Postprandial State
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimization of Exercise Protocol for Prediabetic Population in Postprandial State
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The core purpose of the project is to find out optimal exercise protocol for control of hyperglycemia and insulin resistance in prediabetic The results of the study will increase the current understandings of how exercise can be used in the most efficient manner to extract the maximum possible benefits and enhance adherence in best scientific manner possible
Detailed Description:
Participants will be selected from Peshawar and the study will be carried in accordance with the ethical code of research as per the revised 2013 declaration of Helsinki 1975 The volunteers will be recruited through posters banners and personal contacts The aims objectives purpose and procedure of the study will be explained to each participant A written informed consent from all the participants will be taken after agreement and they will be informed about their right to leave the trial at any time if they dont want
After selection the recruited participants will be asked to attend the lab for 12 visits over 6 months On the day of experiment patients will be received in Lab in fasting state where baseline measurements weight age BMI WH ratio body composition will be determined They will be screened for exercise fitness through PAR_Q and exercise readiness questionnaire Detailed history of the patients Diabetes Mellitus medications and economic conditions and General Physical Examination will be carried out
This study will be triphasic during which optimal timing of the exercise in post prandial state optimal intensity of the exercise and optimal duration of the exercise will be quantified For this a single cohort of 12 participants will be selected with crossover design who will attend the lab 12 times in total for all phases 04 visits for single phase Each participant will attend the lab 12 times in total during the intervention Each participant will be provided with one week time as wash out period
The details of the actual visits of participants to Physiology Skill lab in detail is as under
TIMING Protocol
This protocol is aimed to determine the best possible time for exercise execution in postprandial state for prediabetics During this protocol all the participants will visit the lab 04 times 7 days apart in fasting and will be served with isocaloric breakfast 250 Kcal after which the exercise will be started at different intervals with the following details
Visit 1
The participants will perform exercise 30 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise for determination of blood glucose level insulin lipid profile and MicroRNAs miR-192 miR193b
Visit 2 - The participants will perform exercise 60 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise for determination of blood glucose level insulin lipid profile and MicroRNAs miR-192 miR193b
Visit 3 - The participants will perform exercise 90 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit4 - The participants will perform exercise 120 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
This protocol will provide us an optimal time for exercise in post prandial state
Intensity Protocol
This protocol is aimed to determine the best possible intensity of exercise in postprandial state for prediabetics During this protocol all the participants will visit the lab 04 times at least 2 days apart in fasting and will be served with isocaloric breakfast 250 Kcal after which the exercise will be started at the optimal time determined through previous protocol at different sub maximal intensities with the following details
Visit 1
The participants will perform exercise at 50 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 2 - The participants will perform exercise at 60 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 3 - The participants will perform exercise 70 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit4 - The participants will perform exercise 80 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise However this session might need fitness of the individuals and may be omitted for some participants based on their fitness level
Duration Protocol
This protocol is aimed to determine the best possible duration for exercise in postprandial state for prediabetics During this protocol all the participants will visit the lab 04 times at least 2 days apart in fasting and will be served with isocaloric breakfast 250 Kcal after which the exercise will be started at the optimal time and intensity determined through previous protocols for different durations with the following details
Visit 1
The participants will perform exercise at optimal timing and intensity determined previously for 15 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 2 - The participants will perform exercise at optimal timing and intensity determined previously for 30 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 3 - The participants will perform exercise at optimal timing and intensity determined previously for 45 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit4 - The participants will perform exercise at optimal timing and intensity determined previously for 60 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
However this session might need fitness of the individuals and may be omitted for some participants based on their fitness level
Analysis Procedure
Sample analysis
Blood glucose levels will be determined through glucometer and Insulin levels will be determined through sandwich Elisa MicroRNAs will be extracted and then analyzed through real-time qPCR or microarray analysis
After selection the recruited participants will be asked to attend the lab for 12 visits over 6 months On the day of experiment patients will be received in Lab in fasting state where baseline measurements weight age BMI WH ratio body composition will be determined They will be screened for exercise fitness through PAR_Q and exercise readiness questionnaire Detailed history of the patients Diabetes Mellitus medications and economic conditions and General Physical Examination will be carried out
This study will be triphasic during which optimal timing of the exercise in post prandial state optimal intensity of the exercise and optimal duration of the exercise will be quantified For this a single cohort of 12 participants will be selected with crossover design who will attend the lab 12 times in total for all phases 04 visits for single phase Each participant will attend the lab 12 times in total during the intervention Each participant will be provided with one week time as wash out period
The details of the actual visits of participants to Physiology Skill lab in detail is as under
TIMING Protocol
This protocol is aimed to determine the best possible time for exercise execution in postprandial state for prediabetics During this protocol all the participants will visit the lab 04 times 7 days apart in fasting and will be served with isocaloric breakfast 250 Kcal after which the exercise will be started at different intervals with the following details
Visit 1
The participants will perform exercise 30 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise for determination of blood glucose level insulin lipid profile and MicroRNAs miR-192 miR193b
Visit 2 - The participants will perform exercise 60 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise for determination of blood glucose level insulin lipid profile and MicroRNAs miR-192 miR193b
Visit 3 - The participants will perform exercise 90 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit4 - The participants will perform exercise 120 minutes after a standard isocaloric breakfast provided at the lab Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down at moderate intensity 50 predicted maximum heart rate on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
This protocol will provide us an optimal time for exercise in post prandial state
Intensity Protocol
This protocol is aimed to determine the best possible intensity of exercise in postprandial state for prediabetics During this protocol all the participants will visit the lab 04 times at least 2 days apart in fasting and will be served with isocaloric breakfast 250 Kcal after which the exercise will be started at the optimal time determined through previous protocol at different sub maximal intensities with the following details
Visit 1
The participants will perform exercise at 50 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 2 - The participants will perform exercise at 60 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 3 - The participants will perform exercise 70 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit4 - The participants will perform exercise 80 of predicted maximum heart rate PMHR Each exercise session will last for 40 minutes 05 minutes warm up 05 minutes cool down on treadmill Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise However this session might need fitness of the individuals and may be omitted for some participants based on their fitness level
Duration Protocol
This protocol is aimed to determine the best possible duration for exercise in postprandial state for prediabetics During this protocol all the participants will visit the lab 04 times at least 2 days apart in fasting and will be served with isocaloric breakfast 250 Kcal after which the exercise will be started at the optimal time and intensity determined through previous protocols for different durations with the following details
Visit 1
The participants will perform exercise at optimal timing and intensity determined previously for 15 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 2 - The participants will perform exercise at optimal timing and intensity determined previously for 30 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit 3 - The participants will perform exercise at optimal timing and intensity determined previously for 45 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
Visit4 - The participants will perform exercise at optimal timing and intensity determined previously for 60 minutes excluding warm up and cool down Blood samples 05 ml approximately will be taken at fasting before exercise and 30 and 60 minutes after exercise
However this session might need fitness of the individuals and may be omitted for some participants based on their fitness level
Analysis Procedure
Sample analysis
Blood glucose levels will be determined through glucometer and Insulin levels will be determined through sandwich Elisa MicroRNAs will be extracted and then analyzed through real-time qPCR or microarray analysis
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