Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05233722
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-01-17
Brief Title:
mTOR as Mediator of Insulin Sensitivity Study
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Mechanistic Target of Rapamycin mTOR as Mediator of Exercise-induced Insulin Sensitivity Study
Status:
RECRUITING
Status Verified Date:
2024-05
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 role of mTOR in mediating enhancement of muscle insulin sensitivity following a single bout of exercise
This will be investigated in young healthy male subjects by administering the pharmacological mTOR inhibitor Rapamycin in a crossover blinded experimental setup known to enhance muscle insulin sensitivity following one-legged knee-extensor exercise
This will be investigated in young healthy male subjects by administering the pharmacological mTOR inhibitor Rapamycin in a crossover blinded experimental setup known to enhance muscle insulin sensitivity following one-legged knee-extensor exercise
Detailed Description:
Trial A During trial A the study subject will arrive at the research laboratory and eat a morning meal at 630 am corresponding to 5 of the daily energy requirements It is requested that the study subject will arrive in a car or with public transportation At the same time the subject will ingest 16 mg of Rapamycin or placebo 800 mg Calcium in pill form Following ingestion the study subject will rest for 2 hour and at that time catheters are inserted in both femoral veins the femoral artery in one of the legs and in each forearm vein antecubital veins for later blood sampling and intravenous infusion of insulin glucose stable D2-glucose and stable 13C6-phenylalanine At 830 am the study subjects will perform one-leg knee extension exercise for 1 hour at an intensity of 80 of maximal work capacity In this work protocol there are inserted 3 intervals of 5 minutes duration where the study subject works at 100 of maximal intensity with the purpose of securing a full activationrecruiting of all muscle fibers Immediately following conclusion of the exercise bout 13C6-phenylalanine is infused for later determination of muscle protein synthesis 2 hours into the recovery from exercise D2-glucose is infused for later determination of hepatic glucose production 4 hours into the recovery from exercise an euglycaemic hyperinsulinemic clamp will be initiated for 2 hours for determination of insulin stimulated muscle glucose uptake Muscle biopsies from the m vastus lateralis muscle in one or both legs will be taken before immediately after as well as 2 4 and 6 hours after conclusion of exercise Pulmonary oxygen uptake is measured with the use of an online system before during and after exercise and is used for determination of substrate metabolism Blood samples from the femoral veins in both legs and the femoral artery in one of the legs are drawn before during exercise and during the recovery period after exercise At the same time blood flow is measured in the femoral arteries in both legs with the use of Doppler technique Determination of arteriovenous difference AV difference by simultaneous measurement of blood flow enables us to calculate skeletal muscle glucose uptake and uptakerelease of relevant substances proteins peptides and metabolites etc The experimental part of trial A is completed at 1530 pm The study subject will be given food and drink and will be observed for one hour before they may leave the research laboratory
Trial B is an identical protocol except that the subject will receive opposite drug from trial A Rapamycin or placebo Trial A and B will be separated by a minimum of 14 days
Trial B is an identical protocol except that the subject will receive opposite drug from trial A Rapamycin or placebo Trial A and B will be separated by a minimum of 14 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