Spinal Cord Injury
Conditions
Keywords
Neuromuscular electrical stimulation, Spinal cord injury, Glucose control, Metabolism
Brief summary
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.
Interventions
BEHAVIORALNMES
Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.
BEHAVIORALSham (No Treatment)
Sham stimulation during a 3-h OGTT.
Sponsors
University of Birmingham
University of Bath
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
We are asking all individuals who meet our study criteria if they would like to take part. We are looking for both males and females who meet all the criteria on this list for either SCI or non-injured individuals: Individuals with SCI: * \>1-year postinjury. * 18 years of age or above * American Spinal Cord Injury Impairment Scale A-C. * Level of Injury, Cervical 5-Lumbar 2. * Have capacity to provide informed consent. Non-injured individuals: • 18 years of age or above
Exclusion criteria
* 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 SCI only: * Recently trained with electrical stimulation (\< 6 months) * Recent history of lower limb fractures * Peripheral nerve injury to lower extremities * Unresolved pressure ulcers * Known lower motor neuron injury. * If the research team cannot induce visible or palpable contractions of the quadricep muscle with NMES * If they cannot tolerate the NMES intervention * Has previously experienced uncontrolled autonomic dysreflexia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose incremental area under the curve (iAUC). | 180 minutes | Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT) |
| Glucose Kinetics | 0, 180 minutes post ingestion | 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
| Measure | Time frame | Description |
|---|---|---|
| Non-oxidative glucose disposal | 180 minutes | Non-oxidative glucose disposal |
| Fasting plasma glucose concentration | Baseline | Fasting plasma glucose concentration (mmol/L) |
| Fasting plasma non-esterified fatty acid concentrations | Baseline | Fasting plasma non-esterified fatty acid concentrations (mmol/L) |
| Fasting plasma lactate concentrations | Baseline | Fasting plasma lactate concentrations (mmol/L) |
| Postprandial non-esterified fatty acid concentrations | 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion | Postprandial non-esterified fatty acid concentrations (mmol/L) in response to oral glucose tolerance test |
| Postprandial lactate concentrations | 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion | Postprandial lactate concentrations (mmol/L) in response to OGTT |
| Whole-body carbohydrate oxidation | 0,60,120,180 minutes post-ingestion | Assessed via indirect calorimetry during 180-min OGTT (60-min intervals) |
| Acceptability of at-home NMES | 2-weeks | Acceptability of at-home NMES obtained via a survey and semi-structured interview. |
| Circulating endothelial cells | 0, 60, 120, 180 minutes post-ingestion of OGTT | Circulating endothelial cells count/ml blood |
| Circulating endothelial progenitor cells | 0, 60, 120, 180 minutes post-ingestion of OGTT | Circulating endothelial progenitor cell count/100 leukocytes |
| Tumor Necrosis Factor alpha (TNF-α) | 0, 60, 120, 180 minutes post-ingestion of OGTT | Tumor Necrosis Factor alpha (TNF-α) (pg/mL) |
| Interleukin-6 (IL-6) | 0, 60, 120, 180 minutes post-ingestion of OGTT | Interleukin-6 (IL-6) (pg/mL) |
| Interferon gamma (IFN-γ) | 0,60,120,180 minutes post-ingestion of OGTT | Interferon gamma (IFN-γ) (pg/mL) |
| Total daily energy expenditure | 5 days | Derived from indirect calorimetry and acccelerometry/heart rate monitoring. |
| Whole body fat oxidation | 0, 60, 120, 180 minutes post-ingestion | Assessed via indirect calorimetry during 180-min OGTT (60-min intervals) |
Countries
United Kingdom
Contacts
Primary ContactRebecca A Young
Outcome results
None listed