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Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake (APHRO)

2. april 2013 oppdatert av: University Hospital, Clermont-Ferrand

Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents

The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

Studieoversikt

Status

Suspendert

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.

Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.

During the " rest " session :

Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.

During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.

The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.

Studietype

Intervensjonell

Registrering (Forventet)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

      • Clermont-Ferrand, Frankrike, 63003
        • CHU clermont-ferrand

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

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Overweight adolescents (over the 90 th percentile of the international cut-off point)

  • With a computer and an internet connection
  • Sedentary (according to the IPAQ-A questionnaire)
  • Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

  • Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
  • Drugs that could interfere with the results of the study
  • Surgical intervention in the 3 months
  • Regular consumption of tobacco or Alcohol
  • patients on a diet with caloric restriction
  • Refusal to sign the consent form
  • Regular practice of sport and intensive

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: obesity
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Comparison before and after the physical activity program of the effect of intense exercise on kinetic of secretion of regulation hormones: Leptin, Grhélin, CCK, PYY3-36, GLP-1
Tidsramme: after 3 months of physical activity
after 3 months of physical activity

Sekundære resultatmål

Resultatmål
Tidsramme
Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales
Tidsramme: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of food intake
Tidsramme: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of insulinosensibility
Tidsramme: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of peripheral blood output
Tidsramme: after 3 months of physical activity
after 3 months of physical activity
Comparison, before and after the physical activity program of sleep quality
Tidsramme: agter 3 months of physical activity
agter 3 months of physical activity
Comparison, before and after the physical activity program of physical condition
Tidsramme: after 3 months of physical activity
after 3 months of physical activity

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Etienne Merlin, University Hospital, Clermont-Ferrand

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. oktober 2012

Primær fullføring (Forventet)

1. mai 2014

Studiet fullført (Forventet)

1. juli 2014

Datoer for studieregistrering

Først innsendt

28. februar 2013

Først innsendt som oppfylte QC-kriteriene

2. april 2013

Først lagt ut (Anslag)

5. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. april 2013

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CHU-0149

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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