Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in fat mass (kg)
研究概览
简要总结
This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.
详细描述
Traumatic spinal cord injury (SCI) is a devastating injury resulting from critical incidents like falls, sports- and traffic accidents, demanding lifelong specialist health care services. A major challenge is the prevalence of obesity following metabolic alterations after SCI. Obesity hampers independence and mobility and has a negative impact on quality of life. Accumulation of adipose tissue is reported to be higher than in able-bodied, explaining the high risk of cardiometabolic disease in the SCI population. Food intake is the supreme variable in prevention of obesity after SCI, however there is a paucity in studies investigating nutrition as a measure to prevent and reduce comorbidity. Key questions that remains unanswered are how early adipose tissue accumulates, if nutritional manipulations can prevent obesity and how follow-up can help maintain a healthy lifestyle. In the present PhD-study, we use MRI techniques to quantify changes in body composition in a cohort study the first year after SCI, and we employ a randomized controlled trial to test the efficacy of a nutrition intervention during rehabilitation aiming to prevent obesity. Successful results will be implemented in care-programs at our hospital for those with SCI and similar mobility impairments, with the aim of improving nutrition practice throughout the course of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic spinal cord injury
- •Levels C1-L2
- •American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D
排除标准
- •Glasgow Coma Scale score (GCS) equal to or lower than 13
- •Below 18 years of age
- •Medical issues like impaired cognitive function, progressive disorders and co-morbidities.
研究组 & 干预措施
Standard treatment
Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.
Personalized nutrition therapy
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
干预措施: Personalized nutritional therapy (Behavioral)
结局指标
主要结局
Change in fat mass (kg)
时间窗: Change from Baseline to 12 months follow-up
Bioimpedance analysis (BIA; seca mBCA 525) will be used to assess whole-body composition. Total fat mass (kg) derived from BIA will be used as the primary adiposity outcome. In individuals with spinal cord injury, fluid shifts and changes in fat-free mass can influence BIA estimates; therefore, fat mass will be interpreted together with secondary indices (fat mass index and waist circumference) and body water compartments.
次要结局
- Change in Lipoprotein B(Change from Baseline to 12 months follow-up)
- Change in folic acid(Change from Baseline to 12 months follow-up)
- Change in vitamin B12(Change from Baseline to 12 months follow-up)
- Change in Ferritin(Change from Baseline to 12 months follow-up)
- Change in C-reactive protein (CRP)(Change from Baseline to 12 months follow-up)
- Change in Cholesterol(Change from Baseline to 12 months follow-up)
- Change in Triglycerides(Change from Baseline to 12 months follow-up)
- Change in C-peptid(Change from Baseline to 12 months follow-up)
- Change in vitamin 25-hydroxy-vitamin D₃(Change from Baseline to 12 months follow-up)
- Change in Glycated hemoglobin (HbA1c)(Change from Baseline to 12 months follow-up)
- Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)(Change from Baseline to 12 months follow-up)
- Change in isoprostanes (biomarkers of oxidative stress)(Change from Baseline to 12 months follow-up)
- Change in cardiorespiratory fitness levels ml/kg/min(Change from Baseline to 12 months follow-up)
- Change in cardiorespiratory fitness levels liter/min(Change from Baseline to 12 months follow-up)
- Change in fasting blood glucose level (mmol/Liter)(Change from Baseline to 12 months follow-up)
- Body weight(Change from Baseline to 12 months follow-up)
- Independency in activities of daily living (ADLs)(Change from Baseline to 12 months follow-up)
- Change in adipose tissue(Change from Baseline to 12 months follow-up)
- Changes in Quality of life (QoL)(Changes from Baseline to 12 months follow-up)
- Change in albumin(Change from Baseline to 12 months follow-up)
- Change in fasting glucose(Change from Baseline to 12 months follow-up)
- Change in Creatinine(Change from Baseline to 12 months follow-up)
- Change in Lipoprotein A1(Change from Baseline to 12 months follow-up)
- Body weight(Change from Baseline to 12 months follow-up)
- Change in Fat Mass Index (FMI, kg/m2)(Change from baseline to 12 months follow-up)
- Change in BIA-estimated visceral adipose tissue(Change from baseline to 12 months follow-up)
- Change in Fat-free mass(Change from baseline to 12 months follow-up)
- Waist circumference (WC, cm)(Change from baseline to 12 months follow-up)
- Body mass index (BMI, kg/m²)(Change from baseline to 12 months follow-up.)
- Change in adipose tissue(Change from Baseline to 12 months follow-up)
- Change in fasting blood glucose level (mmol/Liter)(Change from Baseline to 12 months follow-up)
- Change in fasting glucose(Change from Baseline to 12 months follow-up)
- Change in Glycated hemoglobin (HbA1c)(Change from Baseline to 12 months follow-up)
- Change in Cholesterol(Change from Baseline to 12 months follow-up)
- Change in Triglycerides(Change from Baseline to 12 months follow-up)
- Changes in Quality of life (QoL)(Changes from Baseline to 12 months follow-up)
- Independency in activities of daily living (ADLs)(Change from Baseline to 12 months follow-up)
- Change in albumin(Change from Baseline to 12 months follow-up)
- Change in Creatinine(Change from Baseline to 12 months follow-up)
- Change in Lipoprotein A1(Change from Baseline to 12 months follow-up)
- Change in vitamin 25-hydroxy-vitamin D₃(Change from Baseline to 12 months follow-up)
- Change in Lipoprotein B(Change from Baseline to 12 months follow-up)
- Change in folic acid(Change from Baseline to 12 months follow-up)
- Change in vitamin B12(Change from Baseline to 12 months follow-up)
- Change in Ferritin(Change from Baseline to 12 months follow-up)
- Change in C-reactive protein (CRP)(Change from Baseline to 12 months follow-up)
- Change in C-peptid(Change from Baseline to 12 months follow-up)
- Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-α (TNF-α)(Change from Baseline to 12 months follow-up)
- Change in isoprostanes (biomarkers of oxidative stress)(Change from Baseline to 12 months follow-up)
- Change in cardiorespiratory fitness levels ml/kg/min(Change from Baseline to 12 months follow-up)
- Change in cardiorespiratory fitness levels liter/min(Change from Baseline to 12 months follow-up)
研究者
Vegard Strøm
Head of Research Group
Sunnaas Rehabilitation Hospital