About this trial
Overall aim: To identify the impact and acceptability of a novel method of neuromuscular electrical stimulation (NMES) for improving glucose control using a dual stable isotope tracer OGTT in individuals with spinal cord injury (SCI).
Objective 1:
1. To establish the extent to which an acute bout of NMES improves health-related measures of glucose control, compared to a SHAM control trial. 2. To identify the relative magnitude of effect, compared to non-injured control participants (CON).
Hypotheses:
1. NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition. 2. The effect will be greater in individuals with SCI compared to non-injured control participants.
Objective 2:
To investigate the real-world feasibility of NMES as a therapeutic intervention, participants with SCI will be given instructions for 2-weeks of at-home use. In-depth interviews will be conducted to evaluate acceptability and identify areas that could be adapted to effectively implement NMES in a future trial.
Participants will complete two experimental trials in a randomised crossover fashion separated by 7 days which will consist of either a sham control (SHAM) or an acute bout of NMES during a 3-h oral glucose tolerance test (OGTT). Following the experimental trial days, participants with SCI will take home a NMES device and will be given instructions for 2-weeks of at-home NMES use (Figure 1) to assess acceptability and feasibility.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
>1-year postinjury.
18 years of age or above
American Spinal Cord Injury Impairment Scale A-C.
Level of Injury, Cervical 5-Lumbar 2.
Disqualifiers
Has been diagnosed with type 2 diabetes, or actively taking a pharmaceutical to address elevated blood glucose.
Unable to understand explanations and/or provide informed consent.
If you cannot tolerate the NMES intervention
Is pregnant or planning to become pregnant during the study duration
Trial design
Crossover
Treatments tested in this trial
NMES
BehavioralAcute bout of neuromuscular electrical stimulation during a 3-h OGTT.
Sham (No Treatment)
BehavioralSham stimulation during a 3-h OGTT.
Treatment groups
Trial outcomes
Primary outcomes
Glucose incremental area under the curve (iAUC).
Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)
Glucose Kinetics
Glucose kinetics calculated from plasma deuterated glucose enrichment, including rate of appearance of endogenous glucose, rate of disappearance of glucose, and rate of appearance of exogenous glucose.
Secondary outcomes
Whole-body carbohydrate oxidation
Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)
Whole body fat oxidation
Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)
Non-oxidative glucose disposal
Non-oxidative glucose disposal
Fasting plasma glucose concentration
Fasting plasma glucose concentration (mmol/L)
Sponsors and contacts
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University of Bath
Lead sponsor
University of Birmingham
Collaborator