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cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes

15. oktober 2021 oppdatert av: Christophe De Block, University Hospital, Antwerp
Collection of venous blood samples in male T1D patients to evaluate the behavior of different biomarkers (beta-hydroxybutyrate, lactate, glucose) during and after morning Aerobic (60% of VO2 max) and Symptom Limited Maximal Exercise Test.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Compare values and trends of different biomarkers (glucose, lactate and beta-hydroxybutyrate) before, during and after morning aerobic and symptom limited maximal exercise (cycling) to predict glycemic fluctuations (hypo- and hyperglycemic events) during and after exercise in order to create treatment algorithms to prevent these events.

Endpoint:

• Evaluate values and trends of glucose, lactate and beta-hydroxybutyrate before, during and after morning exercise in venous blood.

Studietype

Observasjonsmessig

Registrering (Faktiske)

21

Kontakter og plasseringer

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

Studiesteder

  • Belgia
    • Antwerp
      • Edegem, Antwerp, Belgia, 2650
        • Antwerp University Hospital

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

18 år til 40 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Adult male participants, aged 18-40 years, with Type 1 Diabetes (T1D) treated with Multiple Daily Insulin injections (MDI) and Continuous Subcutaneous Insulin Injections (CSII)

Beskrivelse

Inclusion Criteria:

  • Male adults (18-40 years old) with T1D, diagnosed since > 1 year
  • Using a CGM (Dexcom G5) or willing to wear a CGM (Dexcom G5) for the duration of the study.

The CGM must be applied >48h before the exercise test

  • Participants are on intensified insulin therapy (MDI) or insulin pump therapy (CSII)
  • 6% ≤ HbA1c ≤ 8%
  • Having a self-reported moderate activity level on the iPAQ (Internationally Physical Activity Questionnaire).
  • C-peptide <0.2 nmol/l
  • The Physical Activity Coefficient has not changed in the 2 months prior to the first Exercise Test.
  • 20kg/m2 < BMI < 25kg/m2

Exclusion Criteria:

  • Recently diagnosed T1D (< 12mo)
  • Participants not on MDI or CSII
  • Musculoskeletal disorder that affects cycling or is a contra-indication for vigorous physical activity
  • Cardiorespiratory disease or ECG abnormality that is a contra-indication for vigorous physical activity
  • Having an acute illness (e.g. influenza) that interferes with glucose metabolism
  • Having a metabolic disorder (different from diabetes) or takes drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
  • Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
  • Presence of concomitant pathology such as heart failure, liver failure, kidney failure defined as eGFR <45mL/min
  • Patient not able or willing to sign the patient informed consent

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Annen
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Patients with type 1 diabetes
Patients with type 1 diabetes perform a morning Symptom Limited Maximal Exercise Test (CPET) or a 60-minute morning Aerobic Test (AEX) at 60% VO2peak

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Tidsramme: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Glucose levels in mg/dL during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Change in lactate concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Tidsramme: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Lactate levels in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Change in ketone concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Tidsramme: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
Ketone levels (Beta-hydroxybutyrate) in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.

Samarbeidspartnere og etterforskere

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

Sponsor

University Hospital, Antwerp

Samarbeidspartnere

University of Padova
Campus Bio-Medico University
Université Montpellier
Indigo Diabetes NV

Etterforskere

  • Hovedetterforsker: Christophe De Block, MD, PhD, University Hospital, Antwerp

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

10. mai 2019

Primær fullføring (Faktiske)

13. mai 2020

Studiet fullført (Faktiske)

13. mai 2020

Datoer for studieregistrering

Først innsendt

22. september 2021

Først innsendt som oppfylte QC-kriteriene

15. oktober 2021

Først lagt ut (Faktiske)

28. oktober 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACTION1

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produkt produsert i og eksportert fra USA

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