Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
8 giugno 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
37
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Quebec
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Montreal, Quebec, Canada
- Institut de recherches cliniques de Montreal
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
14 anni e precedenti (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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".
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Full snack given before exercise
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
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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
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Comparatore attivo: 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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Lasso di tempo: This outcome will be measured over 120 minutes
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This time frame corresponds to the exercise period and the 1 hour following it
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This outcome will be measured over 120 minutes
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Lasso di tempo: 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)
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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)
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Percentage of time of glucose levels spent below 4 mmol/L
Lasso di tempo: 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)
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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)
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Decrease in glucose levels
Lasso di tempo: 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)
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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.
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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)
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Increase in glucose level
Lasso di tempo: 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)
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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.
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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)
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Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Lasso di tempo: 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)
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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)
|
|
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Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Lasso di tempo: 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)
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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)
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|
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Number of participants requiring an oral treatment for hypoglycemia
Lasso di tempo: 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)
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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)
|
|
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Total number of hypoglycemia episodes requiring treatment
Lasso di tempo: 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)
|
|
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Percentage of time of glucose levels spent above 10 mmol/L
Lasso di tempo: 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)
|
|
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Mean time (minutes) to the first hypoglycemic event
Lasso di tempo: This outcome will be measured for the exercise period only (60 minutes)
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This outcome will be measured for the exercise period only (60 minutes)
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Mean glucose levels
Lasso di tempo: 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)
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Standard deviation of glucose levels
Lasso di tempo: 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)
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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)
|
|
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Percentage of time of glucose levels between 4 and 10 mmol/L
Lasso di tempo: From the end of the exercise period to dinner time.
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Dinner time will be up to the patient.
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From the end of the exercise period to dinner time.
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Percentage of time of glucose levels between 4 and 10 mmol/L
Lasso di tempo: From the end of the exercise period to midnight (7.5 hours)
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From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Lasso di tempo: From midnight to 6:00 next morning (6 hours)
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From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Mean glucose levels
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
3 agosto 2017
Completamento primario (Effettivo)
2 agosto 2019
Completamento dello studio (Effettivo)
2 agosto 2019
Date di iscrizione allo studio
Primo inviato
6 luglio 2017
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2017
Primo Inserito (Effettivo)
11 luglio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 giugno 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 giugno 2020
Ultimo verificato
1 giugno 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SNACK-1
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .