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| ID | Type | Description | Link |
|---|---|---|---|
| SBF009\1017 | Other Grant/Funding Number | Academy of Medical Sciences |
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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
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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:
Hypotheses:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Injury | Experimental | Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of neuromuscular electrical stimulation (NMES), and the other with a sham condition (SHAM). After the OGTT sessions, participants will complete a 2-week period of at-home NMES use to assess real-world feasibility and acceptability through interviews. |
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| Non-injured Control (CON) | Active Comparator | Age- and sex-matched individuals without SCI. Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of NMES, and the other with a sham condition (SHAM). CON will not participate in the at-home NMES phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMES | Behavioral | Acute bout of neuromuscular electrical stimulation during a 3-h OGTT. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose incremental area under the curve (iAUC). | Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT) | 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. | 0, 180 minutes post ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-body carbohydrate oxidation | Assessed via indirect calorimetry during 180-min OGTT (60-min intervals) | 0,60,120,180 minutes post-ingestion |
| Whole body fat oxidation | Assessed via indirect calorimetry during 180-min OGTT (60-min intervals) |
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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:
Non-injured individuals:
• 18 years of age or above
Exclusion Criteria:
SCI only:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca A Young | Contact | +44 (0)1225 388388 | ray27@bath.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Health, University of Bath | Recruiting | Bath | United Kingdom | BA2 7AY | United Kingdom |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham (No Treatment) | Behavioral | Sham stimulation during a 3-h OGTT. |
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| 0, 60, 120, 180 minutes post-ingestion |
| Non-oxidative glucose disposal | Non-oxidative glucose disposal | 180 minutes |
| Fasting plasma glucose concentration | Fasting plasma glucose concentration (mmol/L) | Baseline |
| Fasting plasma non-esterified fatty acid concentrations | Fasting plasma non-esterified fatty acid concentrations (mmol/L) | Baseline |
| Fasting plasma lactate concentrations | Fasting plasma lactate concentrations (mmol/L) | Baseline |
| Postprandial non-esterified fatty acid concentrations | Postprandial non-esterified fatty acid concentrations (mmol/L) in response to oral glucose tolerance test | 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion |
| Postprandial lactate concentrations | Postprandial lactate concentrations (mmol/L) in response to OGTT | 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion |
| Total daily energy expenditure | Derived from indirect calorimetry and acccelerometry/heart rate monitoring. | 5 days |
| Acceptability of at-home NMES | Acceptability of at-home NMES obtained via a survey and semi-structured interview. | 2-weeks |
| Circulating endothelial cells | Circulating endothelial cells count/ml blood | 0, 60, 120, 180 minutes post-ingestion of OGTT |
| Circulating endothelial progenitor cells | Circulating endothelial progenitor cell count/100 leukocytes | 0, 60, 120, 180 minutes post-ingestion of OGTT |
| Tumor Necrosis Factor alpha (TNF-α) | Tumor Necrosis Factor alpha (TNF-α) (pg/mL) | 0, 60, 120, 180 minutes post-ingestion of OGTT |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6) (pg/mL) | 0, 60, 120, 180 minutes post-ingestion of OGTT |
| Interferon gamma (IFN-γ) | Interferon gamma (IFN-γ) (pg/mL) | 0,60,120,180 minutes post-ingestion of OGTT |
| D014947 | Wounds and Injuries |