Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
8. juni 2020 oppdatert av: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required.
Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level.
In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise.
Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
37
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada
- Institut de recherches cliniques de Montréal
-
-
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
14 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
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: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Full snack given before exercise
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
|
Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
|
|
Aktiv komparator: Distributed snack over exercise period
A snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
|
Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Tidsramme: This outcome will be measured over 120 minutes
|
This time frame corresponds to the exercise period and the 1 hour following it
|
This outcome will be measured over 120 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Decrease in glucose levels
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
Increase in glucose level
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Number of participants requiring an oral treatment for hypoglycemia
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Total number of hypoglycemia episodes requiring treatment
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Mean time (minutes) to the first hypoglycemic event
Tidsramme: This outcome will be measured for the exercise period only (60 minutes)
|
This outcome will be measured for the exercise period only (60 minutes)
|
|
|
Mean glucose levels
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Standard deviation of glucose levels
Tidsramme: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Tidsramme: From the end of the exercise period to dinner time.
|
Dinner time will be up to the patient.
|
From the end of the exercise period to dinner time.
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Tidsramme: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Tidsramme: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Tidsramme: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Tidsramme: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient.
|
From the end of the exercise period to dinner time
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Tidsramme: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Tidsramme: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Tidsramme: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Tidsramme: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Tidsramme: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Tidsramme: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Tidsramme: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Tidsramme: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Number of participants requiring treatment for hypoglycemia
Tidsramme: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Tidsramme: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Tidsramme: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Tidsramme: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Number of hypoglycemic episodes requiring treatment
Tidsramme: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Tidsramme: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Tidsramme: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Mean glucose levels
Tidsramme: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Mean glucose levels
Tidsramme: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Mean glucose levels
Tidsramme: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Mean glucose levels
Tidsramme: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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.
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)
3. august 2017
Primær fullføring (Faktiske)
2. august 2019
Studiet fullført (Faktiske)
2. august 2019
Datoer for studieregistrering
Først innsendt
6. juli 2017
Først innsendt som oppfylte QC-kriteriene
10. juli 2017
Først lagt ut (Faktiske)
11. juli 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SNACK-1
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. .