Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- hepatic lipid content
研究概览
简要总结
Excess ectopic fat deposition is associated with development of cardiovascular and metabolic diseases. This study investigates how lifestyle interventions can have an effect on different sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the clinical and economic value of exercise to supplement a hypocaloric diet is investigated.
Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women during consultations. Also, recruitment posters will be used in the University Hospital of Antwerp and the University of Antwerp. Potential participants meeting all a priori set inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric diet group (usual care) or a group of hypocaloric diet combined with physical fitness training. Both groups will undergo an intake procedure in which personal goals are set and barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by imaging techniques after three and six months of intervention. Based on the known relationship between ectopic fat and cardiovascular outcomes, the short term study results will then be extrapolated to an estimation of the reduction of cardiovascular events.
The following clinical outcomes will be presented: change in ectopic fat in the abdomen (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids), heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The impact of supervised exercise in addition to diet will be expressed in projected healthcare costs and quality adjusted life years.
详细描述
protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87)
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants should be willing to undergo a weight loss intervention and body weight must be stable during the past six months.
- •There will be no upper eligibility criterion for body mass index (BMI) but BMI should be at least 27 kg/m².
排除标准
- •Individuals who have a clinical history of type 2 diabetes, prediabetes (with use of medication), or hypothyroidism will be excluded.
- •when postmenopausal; Premenopausal state will be verified by hormonal data (follicle-stimulation hormone (FSH) < 25 mU/ml and estradiol > 20 pg/ml).
- •Subjects will not be allowed when pregnancy is planned
- •when physical activity is not possible due to problems of the musculoskeletal system
- •when changes in medication (e.g. beta blockers) are advised by an endocrinologist.
- •when smoking
- •when drinking more than two alcoholic consumptions/day or binge drinking (self-reported)
- •when taking medication that influences body weight or metabolism (e.g. tricyclic antidepressants)
- •Since all participants will undergo medical imaging, exclusion criteria related to MRI and CT scans are also applicable.
结局指标
主要结局
hepatic lipid content
时间窗: start - 3 months - 6 months - 12 months
The hepatic lipid content will also be measured by a 3T MRI scanner (SIEMENS MAGNETOM Prisma, Siemens Healthcare AG, Zürich, Germany). The body coil will be positioned around the chest, as the subjects lay supine. MRI data will be acquired using STEAM, with the parameter setting as follows: 3.0 cm³ voxel in the right liver, TR/TE 3000/20 ms, and no water suppression.
visceral fat
时间窗: start - 3 months - 6 months - 12 months
A single slice CT of the abdomen will be used to evaluate cross-sectional abdominal visceral adipose tissue areas at the L4-L5 region. The abdominal fat mass and its distribution in visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) will be calculated by area measurement on the corresponding CT slice.
antropometric and metabolic parameters
时间窗: start - (some at) 3 months - 6 months - 12 months
Every participant will undergo a standard metabolic screening at the beginning of the study. This will include a detailed interview and a clinical examination with anthropometry.
health economic evaluation
时间窗: start - 3 months - 6 months - 9 months - 12 months
questionnaires will be used
intra myocellular lipids
时间窗: start - 3 months - 6 months - 12 months
1H-magnetic resonance spectroscopy (1H-MRs) will be used to quantify lipid levels in the tibialis anterior (slow-twitch) muscle of each subject.The right calf of each subject will be positioned near isocenter surrounded by a body coil within a 3T MRI scanner (SIEMENS MAGNETOM Prisma, Siemens Healthcare AG, Zürich, Germany) following manual shimming on the volume of interest to ensure maximum field homogeneity. The 1H-MRs data will be acquired by a single-voxel Point-Resolved Spectroscopy (PRESS) acquisition. Imaging parameters will be set as follows; repetition time (TR)/echotime (TE) 2000/33 ms, voxel size 15 mm³, and weak water suppression.
pericardial and epicardial fat
时间窗: start - 3 months - 6 months - 12 months
Multislice ECG-triggered CT will be used to measure pericardial and epicardial fat areas. All scans will be performed at end-diastole and slice thickness of 2.5 mm. No contrast liquid will be used. Data will be analyzed using the corresponding workstation (GE, AW Volumeshare 2).
次要结局
未报告次要终点
研究者
Wendy Hens
candidate PHD
Universiteit Antwerpen