Diet and Fat Mass After Traumatic Spinal Cord Injury

Obesity Clinical Trial

Official title:

Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109586
• Other study ID #: REK 2017/2443
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2023
• Source: Sunnaas Rehabilitation Hospital
• Contact: Hanne B Slettahjell, MSc
• Phone: 004748107330
• Email: hannebjorg.slettahjell[@]sunnaas.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 three-part started-up PhD-study, we use MRI techniques to quantify accumulation of adipose tissue in a cohort study the first year after SCI, test the efficacy of a nutrition intervention to prevent obesity in a randomized controlled trial, and finally, we will test the feasibility of guided online-support to promote a healthy lifestyle after discharge from in-patient rehabilitation. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Traumatic spinal cord injury

• Levels C1-L2

• American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Personalized nutritional therapy
Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury

Locations

Country	Name	City	State
Norway	Sunnaas Rehabilitation Hospital	Nesoddtangen	Bjørnemyr

Sponsors (3)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	University of Copenhagen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fat-free mass	Bioimpedance Analysis (BIA) will be used to determine body composition by measuring fat-free mass	Change from Baseline to 12 months follow-up
Secondary	Body weight	Measuring body weight in kilograms (kg)	Change from Baseline to 12 months follow-up
Secondary	Independency in activities of daily living (ADLs)	Spinal Cord Independence Measure (SCIM) III will be used to assess various activities of daily living (ADLs). SCIM III comprises 19 items divided into 3 subscales (self-care, respiration and sphincter management, and mobility). The total SCIM score range from 0 to 100, with the subscales weighted as follows: self-care: scored 0-20; respiration and sphincter management: scored 0-40; and mobility: scored 0-40. Scores are higher in patients that require less assistance or fewer aids to complete basic ADLs.	Change from Baseline to 12 months follow-up
Secondary	Change in adipose tissue	Magnetic resonance imaging (MRI) scanning will be used to determine body composition by quantification of adipose tissues (visceral adipose tissue volume and abdominal subcutaneous adipose tissue volume) and muscle volumes.	Change from Baseline to 12 months follow-up
Secondary	Changes in Quality of life (QoL)	International Spinal Cord Society QoL Basic Dataset. The QoL data set consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a Numeric Self-Rating Scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).	Changes from Baseline to 12 months follow-up
Secondary	Change in albumin	Fasted blood analysis of albumin g/dl	Change from Baseline to 12 months follow-up
Secondary	Change in fasting glucose	Fasted blood analysis of fasting glucose (mmol/L)	Change from Baseline to 12 months follow-up
Secondary	Change in Creatinine	Fasted blood analysis of creatinine umol/L	Change from Baseline to 12 months follow-up
Secondary	Change in Lipoprotein A1	Fasted blood analysis of Lipoprotein A1 (g/L)	Change from Baseline to 12 months follow-up
Secondary	Change in Lipoprotein B	Fasted blood analysis of Lipoprotein B (g/L)	Change from Baseline to 12 months follow-up
Secondary	Change in folic acid	Fasted blood analysis of folic acid (nmol/L)	Change from Baseline to 12 months follow-up
Secondary	Change in vitamin B12	Fasted blood analysis of vitamin B12 pmol/L	Change from Baseline to 12 months follow-up
Secondary	Change in Ferritin	Fasted blood analysis of ferritin ug/L	Change from Baseline to 12 months follow-up
Secondary	Change in C-reactive protein (CRP)	Fasted blood analysis of C-reactive protein mg/l	Change from Baseline to 12 months follow-up
Secondary	Change in Cholesterol	Fasted blood analysis of total cholesterol, high density lipoprotein (HDL) and low density lipoprotein (LDL) mmol/L	Change from Baseline to 12 months follow-up
Secondary	Change in Triglycerides	Fasted blood analysis of triglycerides mmol/L	Change from Baseline to 12 months follow-up
Secondary	Change in C-peptid	Blood analysis of insulin c-peptid pmol/L in a fasted state and 2 hours post oral glucose tolerance test	Change from Baseline to 12 months follow-up
Secondary	Change in vitamin 25-hydroxy-vitamin D3	Fasted blood analysis of 25-hydroxy-vitamin D3 (nmol/L)	Change from Baseline to 12 months follow-up
Secondary	Change in Glycated hemoglobin (HbA1c)	Fasted blood analysis of HbA1c mmol/mol	Change from Baseline to 12 months follow-up
Secondary	Change in Cytokines: Interleukin-6 and -1, Tumor necrosis factor-a (TNF-a)	Fasted blood analysis of Interleukin-6 and -1 Tumor necrosis factor-a (TNF-a) (pg/ml)	Change from Baseline to 12 months follow-up
Secondary	Change in isoprostanes (biomarkers of oxidative stress)	Urine analyses of isoprostanes (ng/mg) (biomarkers of oxidative stress)	Change from Baseline to 12 months follow-up
Secondary	Change in cardiorespiratory fitness levels ml/kg/min	Cardiorespiratory fitness levels will be determined by measuring peak oxygen uptake (VO2peak; ml/kg/min) during maximal exercise testing on a treadmill or ergometry cycle.	Change from Baseline to 12 months follow-up
Secondary	Change in cardiorespiratory fitness levels liter/min	Cardiorespiratory fitness levels will be determined by measuring peak oxygen uptake (VO2peak; liter/min) during maximal exercise testing on a treadmill or ergometry cycle.	Change from Baseline to 12 months follow-up
Secondary	Change in fasting blood glucose level (mmol/Liter)	Standardized oral glucose tolerance test (OGTT) will be used to measure the blood glucose level (mmol/Liter) 2 hours after intake of 75 grams glucose in a fasted state.	Change from Baseline to 12 months follow-up