Exercise and the Menstrual Cycle in Type 1 Diabetes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Luteal Phase Aerobic Exercise, Follicular Phase Aerobic Exercise.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes. Базовые параметры: 18 лет — 50 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effects of the Menstrual Cycle on Blood Glucose Changes During Exercise in Women With Type 1 Diabetes Using Oral Contraceptives
Обзор
Female participants with type 1 diabetes using oral contraceptives will be asked to wear a continuous glucose monitor for at least three days on two separate occasions (once during the last week of active pills and once during the no pill/placebo pill phase of the menstrual cycle). An exercise session (45 minutes of aerobic exercise at 60% VO2peak on a cycle ergometer) will take place at 5 pm on the second day of glucose monitoring.
Подробное описание
Pre-test measures: Interested participants will be invited to the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They will be asked questions related to their menstrual cycle, physical activity levels and medication. Blood pressure will also be measured to assess their eligibility. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. A blood sample will be drawn for assessment of HbA1c. Participants will perform an incremental treadmill test to volitional exhaustion. Indirect calorimetry will be used to assess oxygen consumption and carbon dioxide production to determine the participant's aerobic capacity.
Testing sessions: Participants will perform two testing sessions separated by at least 5 days. One session will take place during the last week of active pill consumption of monophasic hormonal contraceptives. The second session will take place during the placebo pill consumption phase (i.e. menses). Participants will be asked to arrive at the lab at around 4:00 pm for both sessions, which will be randomly assigned. During the sessions, participants will be asked to perform 45 minutes of aerobic exercise on an ergonomic cycle ergometer at 60% of the participant's pre-determined aerobic capacity. Blood samples will be drawn at baseline, at the end of exercise, and an hour post-exercise via an IV catheter. Participants will be asked to match their daily food and insulin intake as closely as possible from one testing session to the next for the day before, day of and day after the testing session. They will also be asked to avoid strenuous exercise and alcohol intake.
A continuous glucose monitor (CGM) sensor will be subcutaneously inserted by one of the investigators (trained by a group from the CGM manufacturer) into the anterior abdominal area of the participant in the morning of the day prior to each testing session. The participant will wear the CGM for at least 24 hours before the exercise session, and at least 24 hours after the exercise session.
Вмешательства
- Поведенческое Luteal Phase Aerobic Exercise
Participants will perform 45 minutes of moderate (60% VO2peak) aerobic exercise on a cycle ergometer during the last week of active pill consumption. - Поведенческое Follicular Phase Aerobic Exercise
Participants will perform 45 minutes of moderate (60% VO2peak) aerobic exercise on a cycle ergometer within 5 days of starting their menses.
Первичные конечные точки
- Blood glucose [Срок оценки: Pre-exercise (0 minutes), post-exercise (45 minutes) and 1 hour post-exercise]
Вторичные конечные точки (8)
- Interstitial glucose (continuous glucose monitoring) [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- coefficient of variation (CV) [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- standard deviation (SD) [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- frequency of hypoglycemia [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- frequency of hyperglycemia [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- percent of time in range [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- percent of time in hypoglycemia [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
- percent of time in hyperglycemia [Срок оценки: 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise]
Критерии участия
Критерии включения
- type 1 diabetes diagnosed for at least 1 year
- regular menses
- using monophasic oral contraceptives
- residing in Edmonton, Alberta and able to visit the lab at the University of Alberta
Критерии исключения
- HbA1c > 9.9%
- frequent and unpredictable hypoglycemia
- change in insulin management strategy within two months of the study
- use of an automated insulin delivery system
- blood pressure > 140/95
- history of cardiovascular disease
- severe peripheral neuropathy
- active proliferative retinopathy
- use of medications (other than insulin) that would affect blood glucose levels
- any musculoskeletal condition that would contraindicate exercise (e.g. sprain, strain, joint injury, etc.)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Канада · 1 центр
- Alberta Diabetes Institute — Edmonton
Идентификаторы
NCT: NCT05188014 · Pro0083867