NCT06704126

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

November 19, 2024

Last Update Submit

August 5, 2025

Conditions

Keywords

Passive movement trainingBlood flow restrictionGlucoseInsulinPassive movement

Outcome Measures

Primary Outcomes (1)

  • Blood glucose level

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

    From pre-meal, every 5 minutes for 150 minutes

Secondary Outcomes (4)

  • Blood insulin level

    Immediately pre-meal, 30 minutes post-meal and 60 minutes post-meal

  • 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

  • Electromyography

    Measured for 30 minutes beginning from movement/control protocol commencement

Other Outcomes (1)

  • Muscular thickness

    Measured immediately post-meal and then again 30 minutes post-meal, on each of the three visits.

Study Arms (3)

Passive movement only

EXPERIMENTAL

Participants undergo passive movement training only

Other: Passive movement

Passive movement + intermittent blood flow restriction

EXPERIMENTAL

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

Other: Passive movement with blood flow restriction

Control

NO INTERVENTION

Sitting still in Biodex only - no movement

Interventions

This study will use a passive movement protocol delivered on a Biodex isokinetic dynamometer at 1Hz for 60 seconds on, 60 seconds off, for a total of 30 minutes.

Passive movement only

This study will use a passive movement protocol delivered on a Biodex isokinetic dynamometer at 1Hz for 60 seconds on, 60 seconds off, for a total of 30 minutes. During the 60 seconds on of passive movement training, blood flow restriction cuffs which will be applied to the legs, will be inflated to cause 80% arterial blood flow occlusion.

Passive movement + intermittent blood flow restriction

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smokers
  • 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
  • Diabetes
  • Allergies to barley, gluten, nuts, almonds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster University

Lancaster, United Kingdom

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paul Hendrickse, PhD

    Lancaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Biomedicine

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 25, 2024

Study Start

December 1, 2024

Primary Completion

July 11, 2025

Study Completion

July 11, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

No benefit to sharing these data.

Locations