The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial (VIGOR)
Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).
Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 1N4
- University Of Calgary
-
Edmonton, Alberta, Kanada, T6G 2R3
- University of Alberta
-
-
Manitoba
-
WInnipeg, Manitoba, Kanada, R3E 3P4
- Manitoba Institute of Child Health
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 4L8
- McMaster University
-
Ottawa, Ontario, Kanada, K1N 6N5
- University of Ottawa
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age: 15-45 years old
- Have lived with type 1 diabetes for at least 2 years
- HbA1c <9.9%
- Currently physically inactive (<150 minutes of self-reported structured physical activity per week)
- Undergone a resting ECG to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise
Exclusion Criteria:
- Have frequent and unpredictable hypoglycaemia
- Had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment
- Are currently participating in structured activity or sport-related activities
- Are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding
- Have conditions that would render physical activity contraindicated including: uncontrolled hypertension (BP>150mmHg systolic or >95mmHg diastolic in a sitting position); severe peripheral neuropathy; history of cardiovascular disease
- Have a cognitive deficit resulting in an inability to provide informed consent
- Currently taking beta blockers
- Currently taking atypical antipsychotics or corticosteroids
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Moderate intensity exercise
150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)
|
|
|
Aktywny komparator: Moderate + Vigorous Intensity Exercise
150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor.
Ramy czasowe: Measured at baseline, and 1, 8,16 and 52 weeks following randomization
|
Measured at baseline, and 1, 8,16 and 52 weeks following randomization
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome.
Ramy czasowe: Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
|
Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B2012:136
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .