Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
8 июня 2020 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
37
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Quebec
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Montreal, Quebec, Канада
- Institut de recherches cliniques de Montréal
-
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
14 лет и старше (Ребенок, Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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".
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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
|
|
Активный компаратор: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Временное ограничение: This outcome will be measured over 120 minutes
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Временное ограничение: 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
Временное ограничение: 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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Decrease in glucose levels
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Total number of hypoglycemia episodes requiring treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
|
|
|
Mean glucose levels
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Mean glucose levels
Временное ограничение: 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)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
3 августа 2017 г.
Первичное завершение (Действительный)
2 августа 2019 г.
Завершение исследования (Действительный)
2 августа 2019 г.
Даты регистрации исследования
Первый отправленный
6 июля 2017 г.
Впервые представлено, что соответствует критериям контроля качества
10 июля 2017 г.
Первый опубликованный (Действительный)
11 июля 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 июня 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 июня 2020 г.
Последняя проверка
1 июня 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SNACK-1
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .