Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bath

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 volunteers

Qualifiers

>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

Design model

Crossover

Treatments tested in this trial

  • NMES

    Behavioral

    Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.

  • Sham (No Treatment)

    Behavioral

    Sham stimulation during a 3-h OGTT.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Spinal Cord InjuryExperimental treatment 2 interventions
Group B: Non-injured Control (CON)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Glucose incremental area under the curve (iAUC).

Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)

Time frame
180 minutes
2

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.

Time frame
0, 180 minutes post ingestion

Secondary outcomes

1

Whole-body carbohydrate oxidation

Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)

Time frame
0,60,120,180 minutes post-ingestion
2

Whole body fat oxidation

Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)

Time frame
0, 60, 120, 180 minutes post-ingestion
3

Non-oxidative glucose disposal

Non-oxidative glucose disposal

Time frame
180 minutes
4

Fasting plasma glucose concentration

Fasting plasma glucose concentration (mmol/L)

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bath

Lead sponsor

University of Birmingham

Collaborator