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EXIT: Prospective Study of the Response to Exercise (EXIT)

29. mars 2016 oppdatert av: Jon McGavock, University of Manitoba

Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents

Background :

Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training.

Methods:

The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test.

Study Hypothesis:

The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Faktiske)

15

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Winnipeg, Canada
        • The Manitoba Institute of Child Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

A community-based convenient sample of overweight adolescents aged 12-18 years with a BMI > 95th centile for age and sex.

Beskrivelse

Inclusion Criteria:

  1. Adolescents (12-18 years)
  2. Body mass index considered obese according to the International Obesity Task Force

Exclusion Criteria:

  1. Adolescents with medication-induced or type 1 diabetes
  2. are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
  3. have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
  4. have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
  5. a history of alcoholism or drug abuse
  6. require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
  7. medication(s) known to cause weight gain
  8. anabolic steroids
  9. weight loss medication(s)
  10. pregnant or planning to be pregnant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Overweight Adolescents Performing Resistance Training
Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period. Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training. This will be the primary exposure variable. After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks. During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral).
We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hepatic Triglyceride Content
Tidsramme: 6 weeks
Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy. After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra. A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post-prandial glucose
Tidsramme: 6 weeks
Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .
6 weeks

Samarbeidspartnere og etterforskere

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Etterforskere

  • Hovedetterforsker: Jon M McGavock, PhD, University of Manitoba

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2014

Primær fullføring (Faktiske)

1. oktober 2015

Studiet fullført (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først innsendt

28. juli 2014

Først innsendt som oppfylte QC-kriteriene

29. juli 2014

Først lagt ut (Anslag)

30. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. mars 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • B2014:064

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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