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临床试验/NCT06704126
NCT06704126已完成不适用

A Crossover Study of Passive Movement Training, With and Without Blood Flow Restriction, to Examine Postprandial Blood Glucose Levels

Lancaster University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2024年12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
11
试验地点
2
主要终点
Blood glucose level

研究概览

简要总结

This study aims to examine the blood sugar response after a meal, and how three different movement protocols may impact the blood sugar level.

Participants will visit the lab on three different occasions. Before each visit the participant will eat a meal we give them and have a cannula (a needle with a tube) put in their arm to allow blood sampling for the visit.

Visit A will be the participant just having their legs moved by the machine, visit B will be the participant having their legs moved by the machine with the addition of blood pressure cuffs on their thighs, and visit C will just be the participant sitting still on the machine.

详细描述

This study will require nine participants to be recruited and enrolled. The aim of the study is to determine the effect of passive movement, with and without blood flow restriction, on blood glucose and insulin primarily. Other outcomes included elsewhere in this registration. The protocol will involve an initial health screening/familiarisation session in the Human Performance Laboratory (HPL) at Lancaster University, followed by three randomly ordered HPL visits per participant. At the beginning of each HPL visit, the participant will be given a standard meal. The design is a crossover study therefore each participant will complete visits A, B and C and act as their own control.

Each of the visits A, B and C will involve consumption of a meal (86g carbohydrate content) and insertion of a cannula to the arm. Blood samples will then be drawn from the cannula at five minute intervals for approximately 3.5 hours. Three gold-top vacutainers will be taken throughout each visit to allow for insulin analysis. Once the blood is sampled, the vacutainer will be left to clot at room temperature for 15 minutes and then spun in a centrifuge at 4°C, 1800 RCF, for 10 minutes. The supernatant will be transferred to a microfuge tube via pipetting and stored at -80°C until analysis at a future date using an enzyme-linked immunosorbent assay (ELISA). In addition, 1ml syringe blood samples will be taken every 5 minutes and ejected onto a non-absorbent pad. A fraction of this ejection on the pad will then drawn up into a capillary tube to be analysed by a Biosen benchtop glucose/lactate analyser.

Visit A will invole the participant sitting on a Biodex isokinetic dynamometer and having both legs passively flexed and extended through 90 degrees, at a frequency of 1Hz for 30 minutes. This will be 60 seconds on, followed by 60 seconds off, repeated 15 times.

Visit B will involve the same as visit A, but with the addition of blood flow restriction intermittently. These are blood pressure bands (VALD AirBands) around the thighs which will inflate and deflate to cause 80% arterial occlusion in their inflated state. These will inflate and deflate in tandem with the passive movement going on and off.

Visit C is a control visit and will involve the participant sitting in the Biodex only with no movement or blood flow restriction occuring.

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
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •18-35 years old, inclusive
  • •Healthy (no known long-term health conditions / acute febrile illness)

排除标准

  • •Recent blood donation (within 12 weeks)
  • •Any medication
  • •Phobia of needles
  • •Blood pressure ≥ 140/90 mmHg, either figure
  • •Any potential atrial fibrillation or cardiovascular health conditions
  • •Allergies to barley, gluten, nuts, almonds

研究组 & 干预措施

Passive movement only

Experimental

Participants undergo passive movement training only

干预措施: Passive movement (Other)

Passive movement + intermittent blood flow restriction

Experimental

Participants undergo passive movement training with blood flow restriction applied intermittently during the passive movement protocol

干预措施: Passive movement with blood flow restriction (Other)

Control

No Intervention

Sitting still in Biodex only - no movement

结局指标

主要结局

Blood glucose level

时间窗: From pre-meal, every 5 minutes for 150 minutes

Obtained by 5 minute interval blood draws from cannula then drawn up by a capillary tube and analysed by Biosen benchtop analyser

次要结局

  • Electromyography(Measured for 30 minutes beginning from movement/control protocol commencement)
  • Blood insulin level(Immediately pre-meal, 30 minutes post-meal and 60 minutes post-meal)
  • Electromyography(Measured for 30 minutes beginning from movement/control protocol commencement)
  • Blood lactate level(From pre-meal, every 5 minutes for 150 minutes)
  • Femoral arterial blood velocity(Measured at 0, 1, 5, 10, 20 and 30 minutes relative to the movement/control protocol commencing)

研究者

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

Paul Hendrickse

Lecturer in Biomedicine

Lancaster University

研究点 (2)

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