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Carbohydrate and Insulin Requirements During Prolonged Fasted Exercise

6. mai 2020 oppdatert av: Michael Riddell, York University

Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) A 50 percent basal rate reduction, performed at exercise onset, with carbohydrate dose of 0.3g/kg/hr

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This project focuses on the effectiveness of various exercise strategies on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on continuous subcutaneous insulin infusion (CSII).

The primary objective of the protocol is to determine if a moderate basal insulin reduction (-50 percent of basal), performed 90-minutes before a 120-minute aerobic exercise session (with 5-minute breaks every 30 minutes of exercise, and a ten minute break mid-exercise), improves the time in target range compared to either a carbohydrate consumption only strategy or insulin reduction (-50 percent) and carbohydrate consumption strategy both performed at the onset of exercise in patients with T1D on CSII therapy. The time in target will be determined for both the exercise period and during a 24-hour window after the end of exercise.

In all three sessions, aerobic exercise (brisk walking) will be performed in the fasted state (minimum 8 hours after the last meal) in the early-morning. The exercise will consist of four 30-minute bouts of walking at 40-50 percent of the participant's pre-determined aerobic capacity, separated by 5-10 minute breaks. The participants exercise intensity will be monitored continuously using heart rate and activity monitors. Blood glucose and blood ketone levels will be monitored throughout exercise.

Each participant will be assigned to a sequence of the three experimental visits through a randomization process. Each exercise session will be separated by at least two days and participants will be expected to complete all sessions within ~ 12 weeks from the time of the baseline/screening visit. Participants will be instructed to apply a new continuous glucose monitor (CGM) sensor between 1-5 days prior, not to perform moderate-to-vigorous exercise 24 hours prior and refrain from caffeine and alcohol 12 hours prior to each study visit. Participants are also instructed not to eat after 2330h the night before arriving to the laboratory and not to give bolus insulin or perform temporary basal rate changes after 0200h on the morning of the exercise visit. Participants are instructed to try to arrive at the laboratory with their blood glucose between 72-270 mg/dL, with no active bolus insulin according to personal CSII device, in the fasted state. If a bolus of insulin was given prior to the exercise session, the session was rescheduled. Females of reproductive capacity performed all three visits in the early follicular phase (days 1-6 of cycle). Participants arrived at the laboratory between 0600h and 1000h. Exercise start time was between 0700h and 1045h, based on participants' choice, and the timing of exercise was kept consistent within participants.

Following each exercise session, the participant will rest for 20-minutes and then leave the laboratory. The participants glucose will be monitored for 24-hours after the standardized exercise. They will also be instructed to perform a standardized basal insulin reduction overnight to help reduce the risk of post-exercise nocturnal hypoglycemia (-20 percent from bedtime for 6 hours).

Studietype

Intervensjonell

Registrering (Faktiske)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada, M3J1P3
        • York University

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 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of presumed autoimmune type 1 diabetes
  • Last HbA1c ≤ 9.9 percent
  • Age: 17+ years
  • Duration of T1D: ≥ 1.5 years
  • Using insulin pump therapy: ≥3 months (at least 0.25 units of insulin per kilogram of body mass)
  • In good general health with no conditions that could impact the outcome of the trial
  • Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria:

  • Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
  • Physician diagnosis of peripheral neuropathy or autonomic neuropathy
  • Medications:

    1. Beta-blockers
    2. Agents that affect hepatic glucose production (xanthine derivatives)
    3. Pramlintide
    4. Any other hypoglycemic agent
  • Participation in other studies involving the administration of an investigational drug or device during the duration of the current study
  • Severe hypoglycemia in the last 3 months, defined as the individual requiring third party assistance or hospitalization

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Carbohydrate (CHO)-only
Carbohydrate dose of 0.3g/kg/hr given every 30 minutes of exercise if blood glucose is in range with usual basal insulin infusion
Strategies for exercise in type 1 diabetes to maintain glucose control
Annen: 50 Percent Basal Rate Reduction (BRR)
A 50 percent basal rate reduction set 90-minutes pre-exercise and throughout exercise
Strategies for exercise in type 1 diabetes to maintain glucose control
Annen: Combo
The combination of a 50 percent basal rate reduction and carbohydrate dose of 0.3g/kg/hr (given every 30 minutes) both at exercise onset
Strategies for exercise in type 1 diabetes to maintain glucose control

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time in glucose target range during exercise intervention
Tidsramme: 140 minutes
The primary outcome measurement is to determine which strategy had the best time in blood glucose target range (4.0-10.0 mmol/L) during the prolonged exercise
140 minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recovery Interstitial Glucose
Tidsramme: 24 hours
Using CGM to measure recovery glucose levels post-exercise to analyze time in target range, time in hypoglycemia (< 4.0 mmol/L) and time in hyperglycemia (> 10.0 mmol/L).
24 hours

Samarbeidspartnere og etterforskere

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

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Michael Riddell, PhD, York University

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)

31. oktober 2018

Primær fullføring (Faktiske)

16. oktober 2019

Studiet fullført (Faktiske)

17. oktober 2019

Datoer for studieregistrering

Først innsendt

6. mai 2020

Først innsendt som oppfylte QC-kriteriene

6. mai 2020

Først lagt ut (Faktiske)

11. mai 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på Type 1 diabetes

Kliniske studier på Exercise strategies

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