Health TrialsbyHealthPanel

mTOR as Mediator of Insulin Sensitivity Study

ConditionInsulin Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age22-35
SponsorUniversity of Copenhagen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy persons (no known disease) without diabetes in the family

No use of medications

Non-smokers

Men

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Exercise

    Other intervention

    1 hour of one-legged knee-extensor exercise followed by 4 hours of rest

  • Insulin infusion

    Procedure/Surgery

    2 hours of Euglycemic Hyperinsulinemic Clamp

  • Placebo

    Drug

    Administration of 800 mg of calcium tablets

  • Rapamycin

    Drug

    Administration of 16 mg of Rapamycin tablets

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Post-exercise insulin sensitivity following placebo administrationPlacebo comparator 3 interventions
Group B: Post-exercise insulin sensitivity following Rapamycin administrationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Insulin stimulated muscle glucose uptake

Muscle glucose uptake during insulin stimulation in recovery from exercise (insulin sensitivity) will be determined based on Fick's principle. Thus, femoral arterio-venous difference (av difference) in blood glucose concentration will be multiplied by femoral arterial leg blood flow.

Time frame
Through study completion, approx. 1 year.

Secondary outcomes

1

Insulin stimulated muscle protein synthesis

Muscle protein synthesis during insulin stimulation in recovery from exercise will be determined based on incorporation of 13C6-phenylalanine in muscle biopsies. Unit of measure is fractional synthesis rate (FSR) in percentage per hour (%/h).

Time frame
1-2 year.
2

Posttranslational modification of proteins in muscle biopsies

The obtained muscle samples will be subjected to mass spectrometry-based phosphoproteomic analysis. This measurement shows posttranslational modification that regulates protein function and will reveal the signalling network underlying the interventions studied. Unit of measure is log2-transformed arbitrary units.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Danish Diabetes Academy

Collaborator

Source ClinicalTrials.gov
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