Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

University of Bath20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injury

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Glucose incremental area under the curve (iAUC).

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

Time frame: 180 minutes

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

Whole-body carbohydrate oxidation

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

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

Whole body fat oxidation

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

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

Non-oxidative glucose disposal

Time frame: 180 minutes

Fasting plasma glucose concentration

Fasting plasma glucose concentration (mmol/L)

Time frame: Baseline

Fasting plasma non-esterified fatty acid concentrations

Fasting plasma non-esterified fatty acid concentrations (mmol/L)

Time frame: Baseline

Fasting plasma lactate concentrations

Fasting plasma lactate concentrations (mmol/L)

Time frame: Baseline

Postprandial non-esterified fatty acid concentrations

Postprandial non-esterified fatty acid concentrations (mmol/L) in response to oral glucose tolerance test

Time frame: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion

Postprandial lactate concentrations

Postprandial lactate concentrations (mmol/L) in response to OGTT

Time frame: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion

Total daily energy expenditure

Derived from indirect calorimetry and acccelerometry/heart rate monitoring.

Time frame: 5 days

Acceptability of at-home NMES

Acceptability of at-home NMES obtained via a survey and semi-structured interview.

Time frame: 2-weeks

Circulating endothelial cells

Circulating endothelial cells count/ml blood

Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

Circulating endothelial progenitor cells

Circulating endothelial progenitor cell count/100 leukocytes

Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

Tumor Necrosis Factor alpha (TNF-α)

Tumor Necrosis Factor alpha (TNF-α) (pg/mL)

Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

Interleukin-6 (IL-6)

Interleukin-6 (IL-6) (pg/mL)

Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

Interferon gamma (IFN-γ)

Interferon gamma (IFN-γ) (pg/mL)

Time frame: 0,60,120,180 minutes post-ingestion of OGTT

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts