The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Mean 24 hour glucose levels (mmol/l)
研究概览
简要总结
Walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. Furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. The primary purpose of this study is to examine how a standardized bout of walking impacts glucose control assessed over 24 hours using continuous glucose monitoring. A secondary purpose is to determine whether responses are influenced by age, sex, and medication use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2D for more than 6 months
- •30-90 years of age
- •No contra-indications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
- •No previous myocardial infarction, stroke or diagnosed coronary artery disease
- •No changes in diabetes medication in last 3 months
- •Not treated by insulin or corticosteroids
- •No significant change in body weight (>5%) in last 3 months
- •Blood pressure <160/100 mmHg; resting HR<100
- •Able to understand English or French and comply with study requirements (e.g., attend visits during the day)
- •Hemoglobin A1C <9.0%
- •No prior history of hypoglycaemia during activity or sleep
排除标准
- •Chest pain during physical activity.
- •Chest pain while resting (no physical activity) in the past month.
- •Loss of balance or consciousness because of dizziness in past 12 months
- •Bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity.
- •Currently pregnant or planning on becoming pregnant in the next 3 months
- •Currently taking exogenous insulin
- •Previous heart attack or stroke
- •Any other reason that prevents ability to walk on a treadmill for 50 minutes
研究组 & 干预措施
Walking
Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes
干预措施: Walking (Behavioral)
Seated Control
Sitting for 50 minutes
干预措施: Seated Control (Behavioral)
结局指标
主要结局
Mean 24 hour glucose levels (mmol/l)
时间窗: 24 hours
Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
次要结局
- Mean amplitude of glycemic excursions (MAGE)(24 hours)
- Standard Deviation of Glucose Values(24 hours)
- Post-dinner glucose control(2 hours following dinner)
- Post-lunch glucose control(2 hours following lunch)
- Post-breakfast glucose control(2 hour following breakfast)
- Time spent above 10 mmol/l glucose(24 hours following walking or seated control)
研究者
Jonathan Little
Assistant Professor
University of British Columbia