- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01636349
Health Effects of Recreational Soccer in Type 2 Diabetic Men
Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men
The present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans, echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12 and 24 weeks, respectively.
The study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Copenhagen, Danmark, 2200
- University of Copenhagen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes diagnosed
- 35-60 years old men
Exclusion Criteria:
- Smoker
- Ischaemic heart Disease
- Congestive heart failure
- Joint or limp pains to an extent where recreational soccer can not be performed.
- Apoplexia.
- Anticoagulant therapy (aspirin accepted)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Recreational soccer training
12 men participate in recreational soccer training for 6 months
|
Recreational soccer or continued unchanged lifestyle
Andre navne:
|
|
Ingen indgriben: Control group
10 subjects serve as a control group with no change in lifestyle in the study period
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiac adaptations
Tidsramme: Analysis of data at baseline, 12 and 24 weeks
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All participants are examined with 2d- echocardiography, speckletracking, strain and colordoppler
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Analysis of data at baseline, 12 and 24 weeks
|
|
muscular adaptations
Tidsramme: Data analysis after baseline, 12 and 24 weeks
|
muscle biopsies are obtaned from the vastus lateralis muscle at baseline, after 12 and 24 weeks, respectively
|
Data analysis after baseline, 12 and 24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vascular function
Tidsramme: Data analysis after baseline, 12 and 24 weeks
|
All subjects are examined with peripheral arterial tonometri (endopat).
Plasma samples and muscle biopsies are analyzed for relevant markers of vascular function
|
Data analysis after baseline, 12 and 24 weeks
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|
glycaemic control
Tidsramme: Data analysis after baseline, 12 and 24 weeks
|
HbA1c, insulin and C-peptide are meassured at baseline, after 12 and 24 weeks, respectively
|
Data analysis after baseline, 12 and 24 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: jakob friis schmidt, MD, University of Copenhagen
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-2-2011-088
- 31964 (Andet bevillings-/finansieringsnummer: F-MARC)
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