Clinical trial NCT02826122: Diastolic Dysfunction During Conservative Lifestyle Treatment
Official title: Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: LHL Helse
First posted: 2016-07-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: diastolic dysfunction
timeFrame: 18 months
Secondary outcomes:
measure: diastolic function
timeFrame: 4 months
measure: diastolic function
timeFrame: 12 months
measure: Cardiorespiratory fitness
timeFrame: 4 months
measure: Cardiorespiratory fitness
timeFrame: 12 months
measure: Cardiorespiratory fitness
timeFrame: 18 months
measure: Body composition
timeFrame: 4 months
measure: Body composition
timeFrame: 12 months
measure: Body composition
timeFrame: 18 months
measure: Body Mass Index
timeFrame: 4 months
measure: Body Mass Index
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 18 months
measure: Waist line
timeFrame: 4 months
measure: Waist line
timeFrame: 12 months
measure: Waist line
timeFrame: 18 months
measure: Physical Activity Questionnaire
timeFrame: 4 months
measure: Physical Activity Questionnaire
timeFrame: 12 months
measure: Physical Activity Questionnaire
timeFrame: 18 months
measure: Quality of life
timeFrame: 4 months
measure: Quality of life
timeFrame: 12 months
measure: Quality of life
timeFrame: 18 months
measure: Symptoms of anxiety and depression
timeFrame: 4 months
measure: Symptoms of anxiety and depression
timeFrame: 12 months
measure: Symptoms of anxiety and depression
timeFrame: 18 months
measure: Glucose concentration in blood
timeFrame: 4 months
measure: Glucose concentration in blood
timeFrame: 12 months
measure: Glucose concentration in blood
timeFrame: 18 months
measure: Glycosylated haemoglobin (HbA1c) concentration in blood
timeFrame: 4 months
measure: Glycosylated haemoglobin (HbA1c) concentration in blood
timeFrame: 12 months
measure: Glycosylated haemoglobin (HbA1c) concentration in blood
timeFrame: 18 months
measure: LDL concentration in blood
timeFrame: 4 months
measure: LDL concentration in blood
timeFrame: 12 months
measure: LDL concentration in blood
timeFrame: 18 months
measure: HDL concentration in blood
timeFrame: 4 months
measure: HDL concentration in blood
timeFrame: 12 months
measure: HDL concentration in blood
timeFrame: 18 months
measure: Concentration of total cholesterol in blood
timeFrame: 4 months
measure: Concentration of total cholesterol in blood
timeFrame: 12 months
measure: Concentration of total cholesterol in blood
timeFrame: 18 months
measure: Concentration of triglycerides in blood serum
timeFrame: 4 months
measure: Concentration of triglycerides in blood serum
timeFrame: 12 months
measure: Concentration of triglycerides in blood serum
timeFrame: 18 months
measure: Concentration of HS-CRP in blood serum
timeFrame: 4 months
measure: Concentration of HS-CRP in blood serum
timeFrame: 12 months
measure: Concentration of HS-CRP in blood serum
timeFrame: 18 months
measure: C-peptide concentration in blood
timeFrame: 4 months
measure: C-peptide concentration in blood
timeFrame: 12 months
measure: C-peptide concentration in blood
timeFrame: 18 months
measure: Leukocyte concentration in blood
timeFrame: 4 months
measure: Leukocyte concentration in blood
timeFrame: 12 months
measure: Leukocyte concentration in blood
timeFrame: 18 months
measure: Potassium (K) concentration in blood
timeFrame: 4 months
measure: Potassium (K) concentration in blood
timeFrame: 12 months
measure: Potassium (K) concentration in blood
timeFrame: 18 months
measure: Sodium (Na) concentration in blood
timeFrame: 4 months
measure: Sodium (Na) concentration in blood
timeFrame: 12 months
measure: Sodium (Na) concentration in blood
timeFrame: 18 months
measure: Creatinine concentration in blood
timeFrame: 4 months
measure: Creatinine concentration in blood
timeFrame: 12 months
measure: Creatinine concentration in blood
timeFrame: 18 months
measure: Apo-A concentration in blood serum
timeFrame: 4 months
measure: Apo-A concentration in blood serum
timeFrame: 12 months
measure: Apo-A concentration in blood serum
timeFrame: 18 months
measure: Apo-B concentration in blood serum
timeFrame: 4 months
measure: Apo-B concentration in blood serum
timeFrame: 12 months
measure: Apo-B concentration in blood serum
timeFrame: 18 months
measure: NT-ProBNP concentration in plasma
timeFrame: 4 months
measure: NT-ProBNP concentration in plasma
timeFrame: 12 months
measure: NT-ProBNP concentration in plasma
timeFrame: 18 months
measure: Lp(a) concentration in blood serum
timeFrame: 4 months
measure: Lp(a) concentration in blood serum
timeFrame: 12 months
measure: Lp(a) concentration in blood serum
timeFrame: 18 months
Other outcomes:
measure: Feasibility
timeFrame: 4 months
measure: Feasibility
timeFrame: 12 months
measure: Feasibility
timeFrame: 18 months
measure: Compliance
timeFrame: 4 months
measure: Compliance
timeFrame: 12 months
measure: Compliance
timeFrame: 18 months
measure: Meal frequency, compliance With a healthier lifestyle
timeFrame: 4 months
measure: Meal frequency, compliance With a healthier lifestyle
timeFrame: 12 months
measure: Meal frequency, compliance With a healthier lifestyle
timeFrame: 18 months
Locations:
city: Røros
country: Norway
facility: LHL-Klinikkene
Study officials:
affiliation: LHL klinikkene / NTNU
name: Line Oldervoll, PhD
role: PRINCIPAL_INVESTIGATOR
References: