Monocentric, Randomized, Controlled Study for Reduction on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients Via Strength Versus Endurance Training (STEN Study - STrength Versus ENdurance Training)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MRI
研究概览
简要总结
In this project, the investigators will test the hypothesis that predominant (two to three times a week 60 min) strength training is more effective in reducing visceral fat mass than endurance training in obese patients.
详细描述
Strength training (ST) was shown to be more effective than endurance training (ET) in improving glycemic control in the treatment of type 2 diabetes. However, it is unknown, whether different training strategies have different effects on the preferential visceral adipose tissue reduction and changes in resting energy expenditure in a population with abdominal obesity. We will therefore compare ST and ET (two to three times a week, 60 minutes per training session) in addition to a restricted energy intake of 1500kcal per day for women and 1800kcal per day for men in a prospective study of 200 individuals with abdominal obesity defined by a waist circumference > 102 cm for males and > 88 cm for females and a BMI > 35 kg/m² with regard to:
- Abdominal visceral adipose tissue area dynamic (MRI studies)
- Abdominal subcutaneous adipose tissue area dynamic (MRI studies)
- Total body fat mass changes (bioelectrical impedance analysis)
- Changes in resting energy expenditure (indirect calorimetry)
- Changes in parameters of glucose metabolism, insulin sensitivity and lipid profile
- Changes in circulating adipokines and markers of inflammation In addition, we will search for novel serum parameters, which predict the individual training response by a serum metabolomics/ proteomics approach.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >= 35 kg/m2
- •waist circumference >102cm (men), >88cm (women)
- •age 18 - 60 years
- •written informed consent
排除标准
- •type 1 or type 2 diabetes
- •fasting plasma glucose >= 6.0 mmol/l
- •2h-OGTT (oral glucose tolerance test) glucose >= 11.1 mmol/l
- •any chronic inflammatory or malignant disease
- •medical treatment which influences glucose metabolism
- •drug or alcohol abuse
- •psychiatric disorders
- •untreated thyroid dysfunction
- •cardiac pacemaker or other contraindication for MRI
- •attendant therapy with oral antidiabetic medication, GLP-1 mimetics or analoga, Insulin, anti-obesity medication (orlistat, sibutramine), Falithrom, antipsychotic drugs, any chemotherapeutics
- •pregnant or nursing women
- •expected low compliance
- •current participation in another investigational trial
- •last exercise training <= 6 months ago
研究组 & 干预措施
endurance training
Endurance training:
Supervised, twice a week, each training session consists of a 20 min warm up and cool down period and a minimum of 40min tread mill, rawing device or bicycle training.
During the study period of 24 months, we will perform an open randomized, prospective training intervention study comparing the effects of three times a week either strength or endurance training on reduction of visceral fat area as determined by MRI scans at the level of L4-L5.
干预措施: exercise training (Procedure)
strength training
Strength training:
Supervised, twice a week, each training session consists of a 20 min warm up and cool down period and a minimum of 40min circle training
During the study period of 24 months, we will perform an open randomized, prospective training intervention study comparing the effects of two to three times a week either strength or endurance training on reduction of visceral fat area as determined by MRI scans at the level of L4-L5.
干预措施: exercise training (Procedure)
结局指标
主要结局
MRI
时间窗: Baseline and after 12 months after randomisation
Change from Baseline in abdominal visceral fat area as determined by MRI scans at the level of L4-L5 after 12 months of training intervention
次要结局
- compliance to the intervention(over 24 months of intervention)
- well being as measured by SF-36(Baseline and every 6 months during intervention)
- fasting plasma glucose(Baseline and every 12 months)
- BIA(Baseline, 6, 12, 18 and 24 months after randomisation)
- adipokine serum concentrations(Baseline and every 3 months during intervention)
- inflammatory parameters(Baseline and every 3 months during intervention)
- MRI(Baseline, 12 and 24 months after randomisation)
- indirect calorimetry(Baseline, 6, 12, 18 and 24 months after randomisation)
研究者
Matthias Bluher
medical doctor
University of Leipzig