Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872426
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-04-29
Brief Title:
Ischemia-reperfusion Exercise Study
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Effect of Ischemia on the Insulin-sensitizing Effect of Exercise
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The study investigates the relationship between activation of AMP-activated protein kinase AMPK in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake
This will be investigated in young healthy lean male subjects
This will be investigated in young healthy lean male subjects
Detailed Description:
This study aims to demonstrate the association between AMPK activation and increased insulin sensitivity in human skeletal muscle The investigators intend to examine insulin sensitivity after various levels of AMPK activation in skeletal muscle that includes exercise at different intensities as well as exercise combined with leg blood flow restriction ischemia The hypothesis is that exercise combined with ischemia will result in an increased activation of AMPK compared to exercise alone and therefore it is expected that exercise combined with ischemia will result in the greatest improvement in muscle insulin sensitivity
Methods
The main experiment consists of 3 experimental days A B and C separated by a minimum of 14 days and carried out in a randomised order On all the study days the participants will arrive in the laboratory after an overnight fast Catheters will be placed in both femoral veins and in one femoral artery A muscle biopsy will be obtained from vastus lateralis of one leg resting leg Experiment A consists of one-legged muscle work for 1 hour at 70 of the leg maximum aerobic work capacity with the other leg serving as a resting control In experiment B the same work are performed but with periodic at the same constricting the blood supply to the working leg 25 seconds every 2 min Experiment C consists of one-legged muscle work for 1 hour at 70 and 95 of the leg maximum aerobic work capacity alternately every 5 min Immediately after each type of exercise a biopsy will be obtained from the exercising leg and the participants will rest in the fasted state for 3 hours before a third set of muscle biopsies from both legs will be obtained Subsequently insulin sensitivity will be evaluated in the participants during a 2-hour physiological hyperinsulinemic euglycemic clamp By the end of the clamp a final set of biopsies both legs will be obtained Throughout the study day sampling of artery and venous bloodplasma samples allows for the estimation of substrate extraction by the two legs Further measures of artery blood flow by Ultrasound Doppler technique allow for the final calculation of substrate uptakerelease across the two legs before exercise during exercise and in recovery from exercise Importantly the ability for insulin to stimulate these processes can be evaluated in both a rested and in a prior exercised leg
Methods
The main experiment consists of 3 experimental days A B and C separated by a minimum of 14 days and carried out in a randomised order On all the study days the participants will arrive in the laboratory after an overnight fast Catheters will be placed in both femoral veins and in one femoral artery A muscle biopsy will be obtained from vastus lateralis of one leg resting leg Experiment A consists of one-legged muscle work for 1 hour at 70 of the leg maximum aerobic work capacity with the other leg serving as a resting control In experiment B the same work are performed but with periodic at the same constricting the blood supply to the working leg 25 seconds every 2 min Experiment C consists of one-legged muscle work for 1 hour at 70 and 95 of the leg maximum aerobic work capacity alternately every 5 min Immediately after each type of exercise a biopsy will be obtained from the exercising leg and the participants will rest in the fasted state for 3 hours before a third set of muscle biopsies from both legs will be obtained Subsequently insulin sensitivity will be evaluated in the participants during a 2-hour physiological hyperinsulinemic euglycemic clamp By the end of the clamp a final set of biopsies both legs will be obtained Throughout the study day sampling of artery and venous bloodplasma samples allows for the estimation of substrate extraction by the two legs Further measures of artery blood flow by Ultrasound Doppler technique allow for the final calculation of substrate uptakerelease across the two legs before exercise during exercise and in recovery from exercise Importantly the ability for insulin to stimulate these processes can be evaluated in both a rested and in a prior exercised leg
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