Oxfordshire Sedentariness, Obesity & Cardiometabolic Risk in Adolescents - a Trial of Exercise in Schools
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Triglyceride
研究概览
简要总结
Obesity is a major cardiovascular disease (CVD) risk factor that is rising fastest in children. Prevention of its damaging effects should begin earlier before they become irreversible. Pilot data identified novel markers of cardiometabolic dysfunction that may be better than body mass index at stratifying risk and as targets for CVD prevention in the young. Advanced imaging, blood tests and a meal-challenge will be used to comprehensively characterise how early metabolic dysfunction (liver and muscle fat, insulin resistance) affects cardiovascular health (arterial stiffness, myocardial energetics, gut vasoreactivity, diastolic function, blood pressure trajectory, left ventricular hypertrophy) in 210 adolescents (110 obese, 50 sedentary normal-weight, 50 high-activity). Reversibility of this phenotype will be tested in the obese by randomised controlled trial, comparing 8-week supervised exercise to a low-activity sham intervention. This study will provide the platform for developing practical, effective CVD prevention in children that is not simply focused on weight-loss.
详细描述
Objectives and Outcome measures
This proposal aims to (1) improve identification of early cardiometabolic dysfunction in children and (2) investigate the reversibility of this dysfunction through exercise. The study will provide the platform for developing practical, effective primordial CVD prevention strategies and the identification of novel early therapeutic targets.
Study Design
This study combines elements of both observational and interventional study designs. A prospective, cross-sectional study of adolescents with 1-year follow-up is combined with a randomised placebo (sham-exercise)-controlled trial (RCT) of eight-weeks of supervised, individualised exercise in an obese sub-population. The RCT is of an established, standardised exercise programme that is low-risk. Group allocation will be known only to the exercise physiologist and staff carrying out the exercise intervention.
Fitness tests will be carried out in schools and in our exercise laboratory, which will provide opportunities to support questionnaire completion, fit accelerometers, fit and return ambulatory blood pressure monitors and address participant questions or concerns. In addition, participants will visit The Oxford Centre for Clinical Magnetic Resonance Research (OCMR) for the initial assessment and for the follow-up assessment for those participants in the obese group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants willing and able to register their informed assent and whose parent(s)/guardian(s), give informed consent for participation of their child in the study
- •Age and sex-appropriate BMI scores using the World Health Organisation standards for obesity and normal weight
- •Objectively measured physical activity
排除标准
- •Contraindications for exercise intervention as determined by the Physical Activity Readiness Questionnaire
- •Safety issues due to behavioural/intellectual limitations
- •Medical Conditions such as neurological disorders or uncontrolled epilepsy
- •Allergies to dairy
- •Type 1 diabetes
- •Pregnancy
- •Contraindications for Magnetic Resonance scans
结局指标
主要结局
Triglyceride
时间窗: Changes from baseline - 8 weeks
Blood plasma (mmol/l) post prandial triglyceride response.
Cardiometabolic phenotype score
时间窗: Changes from baseline - 8 weeks
An additive cardiometabolic phenotype score will be defined as the sum of the z-scores of known elements of cardiometabolic risk with each element scored such that a positive value indicates greater risk. The following elements will be scored positively in the risk model: low cardiac phosphocreatine and adenosine triphosphate (PCr/ATP) ratio z-score by phosphate Magnetic Resonance Spectroscopy (MRS), high aortic pulse wave velocity z-score (arterial stiffness) by Magnetic Resonance (MR), high Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) z-score (insulin resistance), high visceral fat mass z-score by T2\*-IDEAL MR, high left ventricular mass z-score by MR, low peak left ventricular diastolic filling rate z-score by MR, and high 24 hour ambulatory blood pressure z-score.
Superior mesenteric artery blood flow after a meal challenge
时间窗: Changes from baseline - 8 weeks
Assessing the change of blood flow (l/min) in the superior mesenteric artery in response to a meal challenge, measured by phase-contrast MR.
Muscle acetylcarnitine
时间窗: Changes from baseline - 8 weeks
Increased acetylcarnitine is a marker of skeletal muscle metabolism, measured by MRS.
次要结局
- Alanine aminotransferase (ALT)(Changes from baseline - 8 weeks)
- Alkaline Phosphatase (ALP)(Changes from baseline - 8 weeks)
- Total Bilirubin (T.Bil)(Changes from baseline - 8 weeks)
- Self-Regulation of Eating Behaviour Questionnaire(Changes from baseline - 4 weeks and 8 weeks)
- Skeletal muscle lipid(Changes from baseline - 8 weeks)
- Left ventricular mass(Changes from baseline - 8 weeks)
- Weight Related Eating Questionnaire(Changes from baseline - 4 weeks and 8 weeks)
- Visceral fat mass(Changes from baseline - 8 weeks)
- Participant experience(At 8 weeks post baseline and 1 year follow)
- Food Preference Questionnaire(Changes from baseline - 4 weeks and 8 weeks)
- Health Behaviour Questionnaire(Changes from baseline - 4 weeks and 8 weeks)
- Echocardiography - Diastolic Function(Changes from baseline - 8 weeks)
- High Density Lipoprotein (HDL)(Changes from baseline - 8 weeks)
- Low Density Lipoprotein (LDL)(Changes from baseline - 8 weeks)
- Insulin(Changes from baseline - 8 weeks)
- Physical Activity Levels(Changes from baseline - 8 weeks)
- Skeletal muscle glycogen(Changes from baseline - 8 weeks)
- Aspartate Aminotransferase (AST)(Changes from baseline - 8 weeks)
- Haemoglobin A1c (HbA1c)(Changes from baseline - 8 weeks)
- Glucose(Changes from baseline - 8 weeks)
- High Sensitivity C-reactive protein (CRP)(Changes from baseline - 8 weeks)
- Cardiac lipids(Changes from baseline - 8 weeks)
- Full Blood Count (FBC)(Changes from baseline - 8 weeks)
- Cardiac PCr/ATP ratio(Changes from baseline - 8 weeks)
- Aortic pulse wave velocity(Changes from baseline - 8 weeks)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Changes from baseline - 8 weeks)
- Peak left ventricular diastolic filling rate(Changes from baseline - 8 weeks)
- Blood pressure(Changes from baseline - 8 weeks)