- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02951260
The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Physical activity is a first line treatment for patients with type 2 diabetes (T2D ), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated. It is known that metformin and exercise both activates AMPK, which results in many different metabolic effects. Because of this similarity, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. With this study the investigators aim to look at the individual and combined effects of metformin and exercise in order to investigate whether an interaction occur. An Interaction will have tremendous clinical importance for patients with T2D given current guidelines where the vast majority of these patients are recommended both exercise and metformin treatment.
The investigators hypothesize that metformin treatment reduces self-selected exercise intensity, which may be explained via decreased mitochondrial complex 1 function, increased blood lactate levels, heart rate and RPE during exercise. Furthermore exercise-induced AMPK-activation is reduced with metformin treatment.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Copenhagen N
-
Copenhagen, Copenhagen N, Danmark, 2200
- Center for aktiv sundhed
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- male
- HbA1c < 39 mmol/l
- BMI < 25
- structured physical activity < = 150 min/week
- apparently healthy
Exclusion Criteria:
- smoking
- daily pharmaceutical treatment
- contraindication to increased levels of physical activity
- ALAT/ASAT elevated 3 times above upper normal values
- renal insufficiency (eGFR < 60 ml/min)
- prior history of lactic acidosis
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Metformin
17 days metformin treatment
|
17 days treatment with metformin
|
Placebo-jämförare: Placebo
17 days placebo treatment
|
17 days treatment with placebo
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Overall aerobic work performed during an exercise bout with self-selected intensity
Tidsram: Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity
|
Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
External work performed during an exercise bout with self-selected intensity
Tidsram: Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity
|
Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity
|
Rate of perceived exertion during an exercise bout with fixed intensity
Tidsram: Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity
|
Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity
|
blood lactate during an exercise bout with fixed intensity
Tidsram: Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
|
Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
|
Heartrate during an exercise bout with fixed intensity
Tidsram: Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
|
Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
|
Respiratory exchange ratio during an exercise bout with fixed intensity
Tidsram: Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity
|
Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity
|
Physical fitness (VO2max)
Tidsram: maximal oxygen consumption (L/min) during a VO2 max test
|
maximal oxygen consumption (L/min) during a VO2 max test
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
AMPK-activation in skeletal muscle during an exercise bout with fixed intensity
Tidsram: change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity
|
change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity
|
Oxidative phosphorylation in skeletal muscle fibers
Tidsram: Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment
|
Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kristian Karstoft, MD, PhD, Center for aktiv sundhed, Rigshospitalet
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H- 16032037
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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