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临床试验/NCT03908281
NCT03908281已完成不适用

Exercise Training Before (Fasted) Versus After Breakfast in Type 2 Diabetes

University of Alberta2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9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
20
试验地点
2
主要终点
Concentration of HbA1c (mmol/mol)

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 2 diabetes. Training will take place over 16 weeks.

详细描述

People with type 2 diabetes (T2D) are encouraged to increase their physical activity (PA). Sometimes, increasing the amount of PA can be difficult. Therefore, simply recommending that individuals preform more exercise may not be effective in the long term. Recent short-term studies have started to explore how to maximize the effect of a single bout of exercise. For example, short term studies suggest that exercise performed after a meal may decrease blood sugars more than exercise performed after a meal. However, research in people without diabetes shows this may not be the best approach in the long-term. To date, no long-term study has compared the effects of exercise performed at different times of the day in people with T2D.

This study will compare the effects of 16 weeks of regular exercise before breakfast compared to 16 weeks of regular exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to greater improvements in blood sugar control, without the addition of more exercise. It could be very motivating for people with diabetes to know that they can get more benefits from exercise by changing when exercise is performed, rather than trying to increase the amount of 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)

盲法说明

For most outcomes, including the primary outcome, the outcome assessor will be unaware of group allocation.

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosed type 2 diabetes
  • Treated with diet and/or glucose lowering medications, but not insulin, for at least 6 months
  • Sedentary (defined as reaching <150 minutes of aerobic exercise per week)
  • A1C below 9.0%
  • BMI ≥25 kg/m2
  • Central obesity as determined by waist circumference according to Diabetes Canada cutoffs:
  • greater or equal to 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent,
  • greater or equal to 90cm for males of South Asian, Chinese, Japanese, South and Central American descent,
  • greater or equal to 80cm for females
  • Able to walk for 50 minutes

排除标准

  • Consuming more than 10 alcoholic drinks/week
  • History of stroke, myocardial infarction, or coronary artery disease
  • Resting heart rate <100 bpm
  • Resting blood pressure <160/100 mmHg
  • Implantable device, such as a pacemaker, that would not be safe for Magnetic Resonance Imaging

结局指标

主要结局

Concentration of HbA1c (mmol/mol)

时间窗: Change from baseline HbA1c at 16 weeks

Glycated Hemoglobin

Liver fat (%)

时间窗: Change from baseline liver fat at 16 weeks

Intra-hepatic fat measured by Magnetic Resonance Imaging

次要结局

  • Height (centimeters)(Change from baseline height at 16 weeks)
  • Concentrations of Liver enzymes(Change from baseline liver enzymes at 16 weeks)
  • Muscle fat (%)(Change from baseline muscle fat at 16 weeks)
  • Hip circumference (centimeters)(Change from baseline hip circumference at 16 weeks)
  • Body weight (kilograms)(Change from baseline weight at 16 weeks)
  • Continuous glucose monitoring(Change from the first two to the last two weeks of the 16 week interventions)
  • Pancreatic fat (%)(Change from pancreatic fat at 16 weeks)
  • Waist circumference (centimeters)(Change from baseline waist circumference at 16 weeks)
  • Concentrations of Fasting glucose(Change from baseline fasting glucose at 16 weeks)
  • Concentrations of Fasting insulin(Change from baseline fasting insulin at 16 weeks)
  • Concentrations of Fasting lipids(Change from baseline fasting lipids at 16 weeks)
  • Aerobic fitness(Change from baseline aerobic fitness at 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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