NCT02826122
Completed
Not Applicable
Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity
ConditionsObesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- diastolic dysfunction
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI \> 40 kg/m2 (or BMI \> 35 kg/m2 with comorbidity)
- •Stable weight last Three months (≤ 2 kg variation)
- •Norwegian speaking
- •Smartphone
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
diastolic dysfunction
Time Frame: 18 months
echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway
Secondary Outcomes
- LDL concentration in blood(18 months)
- Lp(a) concentration in blood serum(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)
- 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)
- Leukocyte concentration in blood(18 months)
- Potassium (K) concentration in blood(18 months)
Study Sites (1)
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