Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Daily insulin dose (units/kg/day)
研究概览
简要总结
This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 1 diabetes. Training will take place over 12 weeks.
详细描述
People with type 1 diabetes (PwT1D) are encouraged to increase their physical activity (PA). Increasing the amount of PA can be difficult, especially for PwT1D who experience barriers to exercise. Therefore, simply recommending that PwT1D preform more exercise may not be the most effective prescription in the long term. Recent short-term studies have s suggest that exercise performed before eating (fasted) causes blood sugars to decrease less or even increase, compared exercise performed after a meal, which usually causes blood sugar to decrease. To date, no long-term study has compared the effects of exercise performed with or without eating beforehand in people with T1D.
This study will compare the effects of 12 weeks of exercise before breakfast compared to 12 weeks of exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to larger reductions in overall insulin dose, without the addition of more exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes for 5 or more years.
- •Treatment using an insulin pump with no change in treatment modality for > 2 continuous months and willing to share CGM data with the research team. Insulin delivery can be managed using either manual open-loop system (non-AID) or a hybrid closed loop (AID) systems.
- •Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
- •HbA1c 7.0-9.9%.
- •Have BMI of 25 kg/m2 or above
- •Have waist circumference associated with central obesity/metabolic syndrome as per Diabetes Canada definition
- •94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent
- •90cm for males of South Asian, Chinese, Japanese, South and Central American descent
- •80cm for females
- •No history of stroke, myocardial infarction, or coronary artery disease
- •Not wearing implantable device such as a pacemaker, neurostimulators, aneurysm clips, metal fragments, epicardial electrodes, cochlear implants, magnetic ocular implants, penile implants, magnetic tissue expander, some types of breast implants, magnetic orthopedic implants, magnetic dental implants, hearing Aids, intravascular implants, for example VCI filters, coils, stents, cardiac septum implants, ventricular bypass devices.
- •Use a CGM in routine diabetes management.
排除标准
- •Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- •Restriction in aerobic or resistance exercise due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.).
- •Uncontrolled hypertension (e.g., blood pressure >160 mmHg systolic or >100 mmHg diastolic).
- •Implanted device, material, or having a condition contraindicated to MRI.
- •Ongoing pregnancy or breastfeeding.
- •Inability to give consent.
- •Use of an injection-based insulin therapy (ex. multiple daily injections or combined pump and injection-based delivery).
研究组 & 干预措施
Fasted Exercise
Exercise training will be performed in the fasted state (i.e., before breakfast).
干预措施: Fasted Exercise (Behavioral)
Postprandial Exercise
Exercise will be performed in the postprandial period (i.e., after breakfast)
干预措施: Postprandial Exercise (Behavioral)
结局指标
主要结局
Daily insulin dose (units/kg/day)
时间窗: From enrolment to the end of the exercise intervention at week 12.
Total daily insulin dose (including basal and bolus insulin) will be measured over 7 consecutive days.
次要结局
- Continuous glucose monitoring(From enrolment to the end of the exercise intervention at week 12.)
- Feasibility (barriers)(From enrolment to the end of the exercise intervention at week 12.)
- Magnetic resonance imaging (MRI) volumes(From enrolment to the end of the exercise intervention at week 12.)
- Basal and bolus insulin dose (units/kg/day)(From enrolment to the end of the exercise intervention at week 12.)
- Bioelectrical impedance (BIA) in kilograms(From enrolment to the end of the exercise intervention at week 12.)
- Glycated haemoglobin (%)(From enrolment to the end of the exercise intervention at week 12.)
- Concentrations of Fasting glucose(From enrolment to the end of the exercise intervention at week 12.)
- Concentrations of Fasting insulin(From enrolment to the end of the exercise intervention at week 12.)
- Concentrations of Fasting lipids(From enrolment to the end of the exercise intervention at week 12.)
- Aerobic fitness(From enrolment to the end of the exercise intervention at week 12.)
- Body weight (kilograms)(From enrolment to the end of the exercise intervention at week 12.)
- Height (centimeters)(From enrolment to the end of the exercise intervention at week 12.)
- Waist circumference (centimeters)(From enrolment to the end of the exercise intervention at week 12.)
- Hip circumference (centimeters)(From enrolment to the end of the exercise intervention at week 12.)
- Physical Activity in minutes per day(From enrolment to the end of the exercise intervention at week 12.)
- Food logs (kilocalories)(From enrolment to the end of the exercise intervention at week 12.)
- Feasibility (rates expressed as percentage of the total sample)(From enrolment to the end of the exercise intervention at week 12.)
- Feasibility (rates expressed as percentage of the total number of sessions)(From enrolment to the end of the exercise intervention at week 12.)