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临床试验/NCT03553524
NCT03553524撤回不适用

Time of Day Dependant Effects of High Intensity Interval Training on Blood Glucose Levels in Participants With Type 2 Diabetes

Karolinska Institutet1 个研究点 分布在 1 个国家开始时间: 2021年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Compare the efficacy of the morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.

研究概览

简要总结

High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.

详细描述

High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. Additionally, we aim to to elucidate the underlying hormonal changes and fuel utilization preference responsible for the differing blood glucose response.

A randomized cross-over trial with 40 participants with type 2 diabetes will be performed. The participants will be examined on three occasions on an in-patient basis (36-hour hospital visits). On visit 1 baseline (no exercise) measurements will be established. On visit 2 the participants will perform a single bout of HIIT either in the morning (08:30) or afternoon (19:30). After a 1-week washout period, the participants will return for visit 3 and an opposing exercise time. Primarily, the efficacy of the morning and afternoon HIIT will be judged by the continuous glucose monitor (CGM) -based glycaemia measurements. Additionally, during the visits the investigators will collect repeated blood samples to assess the effect of exercise timing on the diurnal hormonal rhythms. Fuel utilization preference will be measured by respiratory exchange ratio (RER)during exercise.

The hypothesis is that afternoon HIIT will be more efficacious in controlling blood glucose values, based on the preliminary data gathered from the 'free living' pilot study. The current study will aim to compare the morning and afternoon exercise in controlled conditions, eliminating the effects of dietary intake, medication and sleep cycle disruption. Additionally, the specific factors responsible for the differing glycaemic response to morning and afternoon exercise will be elucidated.

Preliminary data from the pilot study

A randomised cross-over pilot study with 11 participants with type 2 diabetes in 'free living' conditions has been performed. Glycaemia measurements were collected by continuous glucose monitors (CGMs) for 2 weeks pre-training and for the duration of the study. The participants were assigned to either morning (08:00) or afternoon (16:00) training regime consisting of 6 HIIT occasions over 2 weeks. Following a 2-week 'wash-out' period, the participants performed the opposing exercise training regime. The preliminary results show that HIIT is more efficacious in improving glycaemia when performed in the afternoon, rather than in the morning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 45 - 68 years
  • •Body Mass Index (BMI): 23 - 33 kg/m2
  • •Participant diagnosed with Type 2 Diabetes (insulin independent)
  • •Ability to provide informed consent
  • •Ability to complete the exercise regiment

排除标准

  • •Medications: Insulin
  • •Current nicotine user (cigarettes, snus, nicotine gum)
  • •Past nicotine use less than 6 months before inclusion in the study
  • •Pre-existing cardiovascular condition: Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension
  • •Pre-existing blood-borne disease: HIV, Hepatitis C, MRSA
  • •Pre-existing systemic or localized rheumatic illness
  • •Pre-existing psychiatric disorder
  • •Another pre-existing systemic disease

研究组 & 干预措施

Morning first

Experimental

Both arms of the study will perform the baseline measurements during visit 1. Arm 1 of the study will perform HIIT at 08:30 during visit 2, and after a 1-week washout period will perform HIIT at 19:30 during visit 3.

HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown.

干预措施: morning HIIT --> afternoon HIIT (Other)

Afternoon first

Experimental

Both arms of the study will perform the baseline measurements during visit 1. Arm 2 of the study will perform HIIT at 19:30 during visit 2, and after a 1-week washout period will perform HIIT at 08:30 during visit 3.

HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown.

干预措施: afternoon HIIT --> morning HIIT (Other)

结局指标

主要结局

Compare the efficacy of the morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.

时间窗: 36 hours on: visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT)

Continuous glucose monitor-based blood glucose measurements will be recorded and blood samples will be obtained before and after exercise. Additional repeated blood samples will be collected every 4-6 hours during the stay.

次要结局

  • Respiratory exchange ratio (RER)(During exercise on visit 2 (Arm 1 - Morning HIIT (08:30) / Arm 2 - Afternoon HIIT (19:30)) and visit 3 (Arm 1 - Afternoon HIIT (19:30) / Arm 2 - Morning HIIT (08:30)))
  • Blood insulin levels (mIU/l) will be determined in collected blood samples and compared between exercise interventions (morning vs afternoon HIIT) as well as to no-exercise baseline measurements (morning / afternoon HIIT vs baseline).(Every 4-6 hours during 36 hours on visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT))

研究者

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

Harriet Wallberg

Professor

Karolinska Institutet

研究点 (1)

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