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Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

8. června 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

37

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada
        • Institut de recherches cliniques de Montreal

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

14 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Males and females ≥ 14 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. Last (less than 3 months) HbA1c ≤ 10%.
  4. Patients using multiple daily injections with basal-bolus insulin regimen.

Exclusion Criteria:

  1. 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.
  2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  3. Abnormal blood panel and/or anemia.
  4. Ongoing pregnancy.
  5. Severe hypoglycemic episode within two weeks of screening.
  6. 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).
  7. Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Full snack given before exercise
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
Jiný: 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.
Jiný: Snack
Full snack or Distributed snack
Aktivní komparátor: 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.
Jiný: 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.
Jiný: Snack
Full snack or Distributed snack

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From midnight to 6:00 next morning (6 hours)
From midnight to 6:00 next morning (6 hours)
Number of hypoglycemic episodes requiring treatment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From midnight to 6:00 next morning (6 hours)
From midnight to 6:00 next morning (6 hours)
Mean glucose levels
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Institut de Recherches Cliniques de Montreal

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. srpna 2017

Primární dokončení (Aktuální)

2. srpna 2019

Dokončení studie (Aktuální)

2. srpna 2019

Termíny zápisu do studia

První předloženo

6. července 2017

První předloženo, které splnilo kritéria kontroly kvality

10. července 2017

První zveřejněno (Aktuální)

11. července 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2020

Naposledy ověřeno

1. června 2020

Více informací

Termíny související s touto studií

Klíčová slova

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