Randomised Controlled Trial to Evaluate Impact of Energy Expenditure Information on the Outcome of Weight Loss During a Standardised Multicomponent Weight Management Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Magnitude of weight loss (in kg)
研究概览
简要总结
Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
详细描述
Weight loss is important to improve overall health and reduce risk of obesity-related comorbidities such as diabetes. Numerous studies performed on individuals with predisposed genetic propensity to obesity who are deemed to be metabolically 'thrifty', require further structured intensification of caloric restriction and change in physical activity in order to achieve weight loss. Whether greater weight loss is as a result of smaller reduction in energy expenditure with calorie restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The ECAL device also measures the respiratory quotient (RQ) which is the ratio of the volume of carbon dioxide expired to that of oxygen consumed by the individual for every breath. Previous studies demonstrated variability in role of RQ in predicting weight loss, but individuals who demonstrated an RQ in the lower range (<0.72) were more likely to maintain the weight-loss achieved on a caloric restriction and avoid a weight loss rebound as compared to those with RQ in the higher range (>0.75). This suggests that RQ could prove useful in clinical practice as a prognostic marker for long-term effectiveness of low- and very-low-calorie diets used to induce weight loss. Baltimore Longitudinal Study on Aging shared a similar finding that fasting RQ or respiratory exchange ratio adjusted for age, BMI, and fat free mass was positively related to weight change. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double (Participant, Practitioner) Energy expenditure information (resting energy expenditure & respiratory quotient) is withheld from participant and practitioner providing care to participants in the control group.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > or equivalent to 30 kg/m2 to - 60 kg/m2
- •Stable weight (change of <5% within 12 weeks before screening based on medical history)
- •Subjects are well-motivated, capable and willing to learn how to undergo indirect calorimetry testing
- •Willing and able to adhere to prohibitions and restrictions specified within this protocol
- •For Subjects participating in the glycaemic variability sub-study:
- •Subject understands instructions on the use of continuous glucose monitor sensor and is willing to undergo appropriate training and testing
排除标准
- •Taking weight loss medication within 12 weeks prior to randomisation
- •Previous or planned bariatric surgery
- •History of Type 1, Type 2 diabetes mellitus, DKA or diabetes secondary to pancreatitis
- •Has HbA1c > or equal to 6.5% or Fasting Plasma Glucose > or equal to 7.0 mmol/L at screening.
- •NOTE: a one-time repeat measurement is allowed, if value of HbA1c and/or FPG is not consistent with prior values
- •History of obesity with a known secondary cause (Cushing's disease/syndrome)
- •Oral corticosteroid use (except in the short term use of a 7-10 day course)
- •Ongoing, inadequately controlled thyroid disorder defined as thyroid-stimulating hormone > 6 mIU/litre or < 0.4 mIU/litre
- •History of malignancy within 3 years before screening (or diagnosis of malignancy within this period)
- •estimated glomerular filtration rate < 30 ml/min/1.73m2 on serum testing
- •Alanine aminotransferase level is <2.0 times the upper limit of normal or total bilirubin is >1.5 times the upper limit of normal at screening
- •Other major illness likely to preclude participation in the trial
- •History of glucagonoma
- •A myocardial infarction, unstable angina, revascularisation procedure (stent or bypass graft surgery) or cerebrovascular accident within 12 weeks before screening
结局指标
主要结局
Magnitude of weight loss (in kg)
时间窗: 6 months
次要结局
- modified Total Neuropathy Score(6 months)
- Respiratory Quotient (RQ)(6 months)
- Secretion of gut hormones (GLP-1, GIP, PYY)(6 months)
- Glycaemic variability(6 months)
- Insulin sensitivity(6 months)
- Sensory Neuropathy Testing in Prediabetic Obese Individuals(6 months)
- Resting metabolic rate (RMR)(6 months)
- Douleur Neuropathique en4 Questions (DN4)(6 months)
- Visual analogue score(6 months)
- Brief Pain Inventory Short Form(6 months)
研究者
Prof. John Wilding
Professor of Medicine & Honorary Consultant Physician, Obesity and Endocrinology Research, Theme Lead for Metabolism and Nutrition
University of Liverpool
