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Идёт набор NCT07099911

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Без фазы С лечением Spinal Cord Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NMES, Sham (No Treatment).
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury

Обзор

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.

Вмешательства

  • Поведенческое NMES
    Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.
  • Поведенческое Sham (No Treatment)
    Sham stimulation during a 3-h OGTT.

Первичные конечные точки

  • Glucose incremental area under the curve (iAUC). [Срок оценки: 180 minutes]
  • Glucose Kinetics [Срок оценки: 0, 180 minutes post ingestion]
Вторичные конечные точки (12)
  • Whole-body carbohydrate oxidation [Срок оценки: 0,60,120,180 minutes post-ingestion]
  • Whole body fat oxidation [Срок оценки: 0, 60, 120, 180 minutes post-ingestion]
  • Non-oxidative glucose disposal [Срок оценки: 180 minutes]
  • Fasting plasma glucose concentration [Срок оценки: Baseline]
  • Fasting plasma non-esterified fatty acid concentrations [Срок оценки: Baseline]
  • Fasting plasma lactate concentrations [Срок оценки: Baseline]
  • Postprandial non-esterified fatty acid concentrations [Срок оценки: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion]
  • Postprandial lactate concentrations [Срок оценки: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion]
  • Total daily energy expenditure [Срок оценки: 5 days]
  • Acceptability of at-home NMES [Срок оценки: 2-weeks]
  • Circulating endothelial cells [Срок оценки: 0, 60, 120, 180 minutes post-ingestion of OGTT]
  • Circulating endothelial progenitor cells [Срок оценки: 0, 60, 120, 180 minutes post-ingestion of OGTT]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Великобритания · 1 центр
  • Department for Health, University of Bath — Bath

Идентификаторы

NCT: NCT07099911 · 346844 · SBF009\1017

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗