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临床试验/NCT03626155
NCT03626155已完成不适用

Does Exercise Timing Affect Glucose Levels in People With Diabetes?

University of Alberta2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Mean 24-hour glucose

研究概览

简要总结

It is not clear if there is an optimal time for exercise to improve blood glucose profiles in people with type 2 diabetes. The goal of this study is to compare post meal and 24-hour glucose levels in 4 different conditions: i-seated control, ii-fasted state exercise, iii-30 minutes post meal exercise, and iv- 3-4-hour post meal exercise. The primary outcome of this study is glucose control assessed over 24 hours using continuous glucose monitoring.

详细描述

Purpose:To compare the effects of a single bout of walking conducted at different times of the day on 24-hour glucose profiles in individuals with type 2 diabetes. In addition to a control (no exercise) conditions, a bout of walking will be completed in the following 3 conditions i. in the fasted state, before breakfast, ii. 3-4 hours after lunch, and iii. 30 minutes after dinner.

Background: Recently, we developed the Exercise-Physical Activity and Diabetes Glucose Monitoring (E-PAraDiGM), which was tested at 8 different sites across Canada (ClinicalTrials.gov Identifier: NCT02834689). The original E-PAraDiGM protocol found no significant difference in 24-hour glucose levels between the exercise and seated control condition (publication in preparation). One the of the potential reasons for this could be the timing of exercise in relation to meals. There is no clear consensus as to the optimal time for exercise for individuals with type 2 diabetes. The goal of this study is to expand on the original E-PAraDiGM study by adding fasted state exercise and 30 minute postprandial exercise to the original 2 conditions (3-4 hours after lunch and seated control).

Research Design: The complete protocol will take place over two separate 6-day periods for each participant, which includes 50 minutes of exercise done in the following 4 conditions i. in the fasted state, before breakfast, ii. 3-4hrs after lunch, iii. 30 minutes after dinner, and iv. seated control. Each participant will complete each condition according to a randomized, crossover design.

Participants: Twelve individuals with T2D will be recruited at the University of Alberta. Participants will be between the ages of 30-90 years and will have been diagnosed with T2D for more than 6 months. They will also have no contraindications to exercise, no previous myocardial infarction, strokes, or coronary artery disease. Participants will not be treated with insulin or corticosteroids and they will have had no changes in diabetes medications in the last 3 months. Furthermore, participants will have no significant changes in body weight (>5%) in the last 3 months. Their blood pressure will be below 160/100 mmHg and their resting heart rate will be below 100 beats per minute.

Baseline Assessment: An initial visit will be used to perform screening, obtain written informed consent, and collect baseline data, including: anthropometry (e.g., height, weight, waist/hip circumference), medical history (e.g., duration of diabetes, medications), exercise history (i.e., Godin Leisure Time Exercise Questionnaire), as well as HbA1c, lipids in last 6 months and Creatinine within last year. We will also measure HbA1c with a point of care device (DCA vantage) which requires a single drop of blood (similar demands as a capillary glucose measurements that people with diabetes perform routinely). Body composition with be estimated with bioelectrical impedance analysis (BIA, Tanita TBF-300A). During this initial visit, participants will also have the opportunity to practice walking on a treadmill at the speed and grade that will be assigned during the intervention period (5.0km/hr at a grade of 0.5%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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

入选标准

  • Diagnosed with T2D for more than 6 months
  • 30-90 years of age
  • Able to understand English or French and comply with study requirements (e.g., attend visits during the day)

排除标准

  • Contraindications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
  • Allergies or dietary restriction that could prevent adherence to standardize meals.
  • Previous myocardial infarction, stroke or diagnosed coronary artery disease
  • Changes in diabetes medication in last 3 months
  • Treated by insulin or corticosteroids
  • Change in body weight (>5%) in last 3 months
  • Blood pressure >160/100 mmHg; resting heart rate>100

结局指标

主要结局

Mean 24-hour glucose

时间窗: Within the 24 hours following exercise or control

Glucose measured by continuous glucose monitoring over 24 hours starting at the beginning of exercise on seated control

次要结局

  • Energy expenditure (METs)(Within the 50 minutes of exercise or control)
  • Glucose variability(Within the 24 hours following exercise or control)
  • Respiratory Exchange Ratio (RER)(Within the 50 minutes of exercise or control)
  • Fasting glucose(Within the 24 hours following exercise or control)
  • Postprandial glucose(Within the 24 hours following exercise or control)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Normand Boule

Professor

University of Alberta

研究点 (2)

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