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Clinical trial

Mechanistic Target of Rapamycin (mTOR) as Mediator of Exercise-induced Insulin Sensitivity Study

ID
Name
Rapa Study
Description
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.
Trial arms
Trial start
2022-02-10
Estimated PCD
2029-06-01
Trial end
2029-06-01
Status
Recruiting
Treatment
Exercise
1 hour of one-legged knee-extensor exercise followed by 4 hours of rest
Arms:
Post-exercise insulin sensitivity following Rapamycin administration, Post-exercise insulin sensitivity following placebo administration
Insulin infusion
2 hours of Euglycemic Hyperinsulinemic Clamp
Arms:
Post-exercise insulin sensitivity following Rapamycin administration, Post-exercise insulin sensitivity following placebo administration
Placebo
Administration of 800 mg of calcium tablets
Arms:
Post-exercise insulin sensitivity following placebo administration
Rapamycin
Administration of 16 mg of Rapamycin tablets
Arms:
Post-exercise insulin sensitivity following Rapamycin administration
Size
10
Primary endpoint
Insulin stimulated muscle glucose uptake
Through study completion, approx. 1 year.
Eligibility criteria
Inclusion Criteria: * Healthy persons (no known disease) without diabetes in the family * No use of medications * Non-smokers * Men * Age 22-35 years * Physical activity level (VO2peak) between 30-50 mL O2/min/kg * BMI between 18.0 and 25.0 Exclusion Criteria: * Women * Physical activity (e.g., running, cycling, fitness, etc.) above 6 hours a week. * Persons who show signs of metabolic diseases, hematologic diseases, reduced liver function, human immunodeficiency virus (HIV), hepatitis, thyroid diseases or other signs of disease that may affect the outcome of the study or the study subject's wellbeing will be excluded. * Acute sickness less than 2 weeks prior to study start. * If disease appears or is identified and/or a need for medication arises after inclusion but before initiation of the study. Disease during conclusion of the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The participant will be blinded upon receiving the drug. 4-5 researchers will conduct various measurements on the subject upon each experimental day. Only the clinical responsible will know which drug is administered, while the remaining researchers will be blinded.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2024-05-16

1 organization

2 drugs

1 indication

Organization
University of Copenhagen
Drug
Varlilumab
Indication
Insulin Sensitivity
Drug
rapamycin