Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glucose incremental area under the curve (iAUC).
研究概览
简要总结
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:
- To establish the extent to which an acute bout of NMES improves health-related measures of glucose control, compared to a SHAM control trial.
- To identify the relative magnitude of effect, compared to non-injured control participants (CON).
Hypotheses:
- NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Have capacity to provide informed consent.
- •Non-injured individuals:
- •18 years of age or above
排除标准
- •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
- •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
研究组 & 干预措施
Spinal Cord Injury
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.
干预措施: NMES (Behavioral)
Spinal Cord Injury
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.
干预措施: Sham (No Treatment) (Behavioral)
Non-injured Control (CON)
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.
干预措施: NMES (Behavioral)
Non-injured Control (CON)
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.
干预措施: Sham (No Treatment) (Behavioral)
结局指标
主要结局
Glucose incremental area under the curve (iAUC).
时间窗: 180 minutes
Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)
Glucose Kinetics
时间窗: 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.
次要结局
- Non-oxidative glucose disposal(180 minutes)
- Fasting plasma glucose concentration(Baseline)
- Fasting plasma lactate concentrations(Baseline)
- Total daily energy expenditure(5 days)
- Acceptability of at-home NMES(2-weeks)
- Circulating endothelial cells(0, 60, 120, 180 minutes post-ingestion of OGTT)
- Postprandial lactate concentrations(15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion)
- Postprandial non-esterified fatty acid concentrations(15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion)
- Whole-body carbohydrate oxidation(0,60,120,180 minutes post-ingestion)
- Whole body fat oxidation(0, 60, 120, 180 minutes post-ingestion)
- Non-oxidative glucose disposal(180 minutes)
- Fasting plasma glucose concentration(Baseline)
- Fasting plasma non-esterified fatty acid concentrations(Baseline)
- Fasting plasma lactate concentrations(Baseline)
- Total daily energy expenditure(5 days)
- Circulating endothelial progenitor cells(0, 60, 120, 180 minutes post-ingestion of OGTT)
- Tumor Necrosis Factor alpha (TNF-α)(0, 60, 120, 180 minutes post-ingestion of OGTT)
- Interleukin-6 (IL-6)(0, 60, 120, 180 minutes post-ingestion of OGTT)
- Interferon gamma (IFN-γ)(0,60,120,180 minutes post-ingestion of OGTT)
研究者
Jennifer Maher
PhD Programme for Health
University of Bath