NCT02826122已完成不适用
Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- diastolic dysfunction
研究概览
简要总结
The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in patients with morbid obesity attending a conservative lifestyle change program, 2) investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality of life and cardiovascular risk through the program, 3) investigate feasibility of introducing two different activity monitors throughout the program, and 4) comparing compliance to activity sensor market leader FitBit Application versus Mio Pai Application
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 40 kg/m2 (or BMI > 35 kg/m2 with comorbidity)
- •Stable weight last Three months (≤ 2 kg variation)
- •Norwegian speaking
- •Smartphone
排除标准
- •Other weight reduction treatment, including medication affecting appetite
- •Known chronic cardiac condition
- •Previous bariatric surgery
- •Alcohol or other substitute abuse
- •Psychiatric disorder needing treatment, including eating disorders
- •Pregnancy or planned pregnancy during project period
研究组 & 干预措施
FitBit APP
Active Comparator
FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.
干预措施: FitBit APP (Device)
Pai APP
Experimental
Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.
干预措施: Pai APP (Device)
结局指标
主要结局
diastolic dysfunction
时间窗: 18 months
echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway
次要结局
- Leukocyte concentration in blood(18 months)
- Potassium (K) concentration in blood(18 months)
- LDL concentration in blood(18 months)
- Concentration of HS-CRP in blood serum(18 months)
- C-peptide concentration in blood(18 months)
- Apo-A concentration in blood serum(18 months)
- Glucose concentration in blood(18 months)
- NT-ProBNP concentration in plasma(18 months)
- Lp(a) concentration in blood serum(18 months)
- Physical Activity Questionnaire(18 months)
- diastolic function(12 months)
- Symptoms of anxiety and depression(18 months)
- HDL concentration in blood(18 months)
- Cardiorespiratory fitness(18 months)
- Waist line(18 months)
- Quality of life(18 months)
- Concentration of triglycerides in blood serum(18 months)
- Sodium (Na) concentration in blood(18 months)
- Apo-B concentration in blood serum(18 months)
- Body composition(18 months)
- Body Mass Index(18 months)
- Glycosylated haemoglobin (HbA1c) concentration in blood(18 months)
- Concentration of total cholesterol in blood(18 months)
- Creatinine concentration in blood(18 months)
- Sodium (Na) concentration in blood(4 months)
- Glycosylated haemoglobin (HbA1c) concentration in blood(4 months)
- Sodium (Na) concentration in blood(12 months)
- Creatinine concentration in blood(4 months)
- Creatinine concentration in blood(12 months)
- Glycosylated haemoglobin (HbA1c) concentration in blood(12 months)
- Concentration of triglycerides in blood serum(4 months)
- Concentration of triglycerides in blood serum(12 months)
- diastolic function(4 months)
- Cardiorespiratory fitness(4 months)
- Potassium (K) concentration in blood(12 months)
- Cardiorespiratory fitness(12 months)
- Body composition(4 months)
- Body composition(12 months)
- Body Mass Index(4 months)
- Body Mass Index(12 months)
- Waist line(4 months)
- Waist line(12 months)
- Physical Activity Questionnaire(4 months)
- Physical Activity Questionnaire(12 months)
- Quality of life(4 months)
- Quality of life(12 months)
- Symptoms of anxiety and depression(4 months)
- Symptoms of anxiety and depression(12 months)
- Glucose concentration in blood(4 months)
- Glucose concentration in blood(12 months)
- LDL concentration in blood(4 months)
- LDL concentration in blood(12 months)
- HDL concentration in blood(4 months)
- HDL concentration in blood(12 months)
- Concentration of total cholesterol in blood(4 months)
- Concentration of total cholesterol in blood(12 months)
- Concentration of HS-CRP in blood serum(4 months)
- Concentration of HS-CRP in blood serum(12 months)
- C-peptide concentration in blood(4 months)
- C-peptide concentration in blood(12 months)
- Leukocyte concentration in blood(4 months)
- Leukocyte concentration in blood(12 months)
- Potassium (K) concentration in blood(4 months)
- Apo-A concentration in blood serum(4 months)
- Apo-A concentration in blood serum(12 months)
- Apo-B concentration in blood serum(4 months)
- Apo-B concentration in blood serum(12 months)
- NT-ProBNP concentration in plasma(4 months)
- NT-ProBNP concentration in plasma(12 months)
- Lp(a) concentration in blood serum(4 months)
- Lp(a) concentration in blood serum(12 months)
研究者
研究点 (1)
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