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临床试验/NCT03284216
NCT03284216已完成不适用

The Effects of Hyperglycemia on the Response to Acute Exercise.

University of Birmingham2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Exercise-induced change in blood glucose control.

研究概览

简要总结

This study will determine whether exposure to short-term high blood glucose levels impairs exercise-induced adaptations in glucose tolerance, and whether the pattern of high blood glucose levels plays a role.

详细描述

Healthy male volunteers will undergo a screening visit and four experimental trials.

Screening Visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health Questionnaire will be completed. Body weight, height, and skinfold measurements will be taken. Participants will also complete an exercise test to measure V̇O2max test along with heart rate and blood pressure measurements.

Individuals eligible for inclusion in the study will then return to the lab for four experimental trials, each separated by ~1 week. Trials will be completed using a randomised, counter-balanced, cross-over design. Between experimental trials, participants will be instructed to maintain their normal diet and activity habits. During the 48 hours prior to each experimental trial participants will be instructed to refrain from vigorous exercise and alcohol. For 3 days prior to each experimental trial, participants will record their dietary intake, and wear an accelerometer and a continuous glucose monitor to measure physical activity levels and glucose control.

Experimental Trials: Participants will arrive at the laboratory in the morning (~8 am) following an overnight (~10 hour) fast from food and drink (except water) since 10pm the previous evening. Upon entering the laboratory, body composition (height, weight, waist circumference) will be assessed and a cannula will be placed into a vein in each arm (one for infusion of glucose, one for blood sampling). Resting cardiovascular measures (heart rate, blood pressure, oxygen saturation) will be collected followed by an assessment of cognitive function followed immediately by one of the four 3.5 hour interventions:

  • Trial A (normoglycaemia prior to exercise): This will involve no glycaemic intervention and the participant will remain in a rested, normoglycaemic state throughout all subsequent procedures.
  • Trial B (steady hyperglycaemia prior to exercise): This will involve a continuous constant-rate glucose infusion to establish a steady hyperglycaemic profile. Specifically, 1.2g/kg glucose will be infused at a constant infusion rate across 3.5 hrs (equivalent to 5.71 mg/kg/min).
  • Trial C (fluctuating hyperglycaemia prior to exercise): This will involve repeated glucose injections so as to cause multiple fluctuations in glycaemia. Specifically, 1.2 g/kg glucose will be infused via 8 equal boluses every 30 minutes across 3.5 hrs (the equivalent of 0.15 g/kg per bolus infused over 3.5 minutes at a rate of 42.86 mg/kg/min) interspersed with periods of no infusion.
  • Trial D (normoglycaemia, no exercise): This will be identical to trial A, except there will be no exercise bout.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Aged between 18 and 50 years.
  • Body Mass Index of between 19 and 30 kg/m2.

排除标准

  • Regularly use of anti-inflammatory medication.
  • More than 2 kg weight change in the last 6 months, and/or have undergone weight loss surgery.
  • Previous or current cancer or chronic haematological, pulmonary, cardiac, hepatic, renal, metabolic, or gastrointestinal diseases.
  • Currently engaged in moderate or vigorous exercise on more than 5 days per week.
  • Contraindication to exercise.

研究组 & 干预措施

Normal glycemia + exercise

Other

Participants will be studied in the fasting state under normal blood glucose conditions whereby no glucose will be administered, but an exercise bout will be completed.

干预措施: Exercise (Behavioral)

Steady-state hyperglycemia + exercise

Experimental

Participants will be studied during experimental steady-state hyperglycemia-induced via a variable-rate intravenous glucose infusion, and an exercise bout will be completed.

干预措施: Steady-state hyperglycemia (Procedure)

Steady-state hyperglycemia + exercise

Experimental

Participants will be studied during experimental steady-state hyperglycemia-induced via a variable-rate intravenous glucose infusion, and an exercise bout will be completed.

干预措施: Exercise (Behavioral)

Fluctuating hyperglycemia + exercise

Experimental

Participants will be studied during experimental fluctuating hyperglycemia-induced via repeated intravenous glucose injections, and an exercise bout will be completed.

干预措施: Fluctuating hyperglycemia (Procedure)

Fluctuating hyperglycemia + exercise

Experimental

Participants will be studied during experimental fluctuating hyperglycemia-induced via repeated intravenous glucose injections, and an exercise bout will be completed.

干预措施: Exercise (Behavioral)

Normal glycemia, no exercise

No Intervention

Participants will be studied in the fasting state under normal blood glucose conditions whereby no glucose will be administered and no exercise will be completed.

结局指标

主要结局

Exercise-induced change in blood glucose control.

时间窗: In all trials, glucose control will be determined between the time-point immediately after exercise and 24 hours after exercise.

In all trials, continuous glucose monitoring (CGM) will be used to assess the change in glucose control compared to baseline for 24 hours after-exercise, under diet-controlled but otherwise free-living conditions.

次要结局

  • Hyperglycemia-induced change in inflammation.(In all trials, inflammation will be determined at baseline (T=0 hours) and at T=3.5 hours. The glycemic interventions take place between baseline (T=0 hours) and T=3.5 hours.)
  • Hyperglycemia-induced change in cognitive function.(In all trials, cognitive function will be determined at baseline (T=0 hours) and at T=3.5 hours. The glycemic interventions take place between baseline (T=0 hours) and T=3.5 hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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