Obesity Clinical Trial
Official title:
Prevalence of Diastolic Dysfunction and Effects of Conservative Lifestyle Treatment in Patients With Morbid Obesity
| NCT number | NCT02826122 |
| Other study ID # | 2016/833 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2016 |
| Est. completion date | August 2018 |
| Verified date | August 2018 |
| Source | Norwegian University of Science and Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | August 2018 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | LHL-Klinikkene | Røros |
| Lead Sponsor | Collaborator |
|---|---|
| Norwegian University of Science and Technology | LHL Helse |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Feasibility | measured as attrition rate, Activity sensor errors | 4 months | |
| Other | Feasibility | measured as attrition, Activity sensor errors, | 12 months | |
| Other | Feasibility | measured as attrition, Activity sensor errors, | 18 months | |
| Other | Compliance | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods | 4 months | |
| Other | Compliance | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods | 12 months | |
| Other | Compliance | actual use of Activity sensors; obtaining 80 % or more of prescribed physical Activity in home periods | 18 months | |
| Other | Meal frequency, compliance With a healthier lifestyle | HUNT 3 questionnaire | 4 months | |
| Other | Meal frequency, compliance With a healthier lifestyle | HUNT 3 questionnaire | 12 months | |
| Other | Meal frequency, compliance With a healthier lifestyle | HUNT 3 questionnaire | 18 months | |
| Primary | diastolic dysfunction | echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway | 18 months | |
| Secondary | diastolic function | echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway | 4 months | |
| Secondary | diastolic function | echocardiac examination assessed by GE Healthcare Vivid E9, Horten, Norway | 12 months | |
| Secondary | Cardiorespiratory fitness | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany | 4 months | |
| Secondary | Cardiorespiratory fitness | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany | 12 months | |
| Secondary | Cardiorespiratory fitness | Peak oxygen uptake assessed by Jaeger oxycon pro; Erich Jaeger GmbH, Hoechberg, Germany | 18 months | |
| Secondary | Body composition | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) | 4 months | |
| Secondary | Body composition | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) | 12 months | |
| Secondary | Body composition | Body composition assessed by bioelectrical impedance (instrument InBody 770, produced by BIOSPACE, Seoul, Korea) | 18 months | |
| Secondary | Body Mass Index | Weight derived by squared height | 4 months | |
| Secondary | Body Mass Index | Weight derived by squared height | 12 months | |
| Secondary | Body Mass Index | Weight derived by squared height | 18 months | |
| Secondary | Waist line | tape measure in centimeters | 4 months | |
| Secondary | Waist line | tape measure in centimeters | 12 months | |
| Secondary | Waist line | tape measure in centimeters | 18 months | |
| Secondary | Physical Activity Questionnaire | HUNT 1 physical activity questionnaire | 4 months | |
| Secondary | Physical Activity Questionnaire | HUNT 1 physical activity questionnaire | 12 months | |
| Secondary | Physical Activity Questionnaire | HUNT 1 physical activity questionnaire | 18 months | |
| Secondary | Quality of life | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin | 4 months | |
| Secondary | Quality of life | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin | 12 months | |
| Secondary | Quality of life | Impact of Weight on Quality of Life Short Form (IWQOL-Lite); Kolotkin | 18 months | |
| Secondary | Symptoms of anxiety and depression | Hospital Anxiety and Depression Scale; Zigmond & Snaith | 4 months | |
| Secondary | Symptoms of anxiety and depression | Hospital Anxiety and Depression Scale; Zigmond & Snaith | 12 months | |
| Secondary | Symptoms of anxiety and depression | Hospital Anxiety and Depression Scale; Zigmond & Snaith | 18 months | |
| Secondary | Glucose concentration in blood | 4 months | ||
| Secondary | Glucose concentration in blood | 12 months | ||
| Secondary | Glucose concentration in blood | 18 months | ||
| Secondary | Glycosylated haemoglobin (HbA1c) concentration in blood | 4 months | ||
| Secondary | Glycosylated haemoglobin (HbA1c) concentration in blood | 12 months | ||
| Secondary | Glycosylated haemoglobin (HbA1c) concentration in blood | 18 months | ||
| Secondary | LDL concentration in blood | Low Density Cholesterol | 4 months | |
| Secondary | LDL concentration in blood | Low Density Cholesterol | 12 months | |
| Secondary | LDL concentration in blood | Low Density Cholesterol | 18 months | |
| Secondary | HDL concentration in blood | High Density Cholesterol | 4 months | |
| Secondary | HDL concentration in blood | High Density Cholesterol | 12 months | |
| Secondary | HDL concentration in blood | High Density Cholesterol | 18 months | |
| Secondary | Concentration of total cholesterol in blood | 4 months | ||
| Secondary | Concentration of total cholesterol in blood | 12 months | ||
| Secondary | Concentration of total cholesterol in blood | 18 months | ||
| Secondary | Concentration of triglycerides in blood serum | 4 months | ||
| Secondary | Concentration of triglycerides in blood serum | 12 months | ||
| Secondary | Concentration of triglycerides in blood serum | 18 months | ||
| Secondary | Concentration of HS-CRP in blood serum | High Sensitive C-reactive protein | 4 months | |
| Secondary | Concentration of HS-CRP in blood serum | High Sensitive C-reactive protein | 12 months | |
| Secondary | Concentration of HS-CRP in blood serum | High Sensitive C-reactive protein | 18 months | |
| Secondary | C-peptide concentration in blood | 4 months | ||
| Secondary | C-peptide concentration in blood | 12 months | ||
| Secondary | C-peptide concentration in blood | 18 months | ||
| Secondary | Leukocyte concentration in blood | 4 months | ||
| Secondary | Leukocyte concentration in blood | 12 months | ||
| Secondary | Leukocyte concentration in blood | 18 months | ||
| Secondary | Potassium (K) concentration in blood | 4 months | ||
| Secondary | Potassium (K) concentration in blood | 12 months | ||
| Secondary | Potassium (K) concentration in blood | 18 months | ||
| Secondary | Sodium (Na) concentration in blood | 4 months | ||
| Secondary | Sodium (Na) concentration in blood | 12 months | ||
| Secondary | Sodium (Na) concentration in blood | 18 months | ||
| Secondary | Creatinine concentration in blood | 4 months | ||
| Secondary | Creatinine concentration in blood | 12 months | ||
| Secondary | Creatinine concentration in blood | 18 months | ||
| Secondary | Apo-A concentration in blood serum | Apolipoprotein A | 4 months | |
| Secondary | Apo-A concentration in blood serum | Apolipoprotein A | 12 months | |
| Secondary | Apo-A concentration in blood serum | Apolipoprotein A | 18 months | |
| Secondary | Apo-B concentration in blood serum | Apolipoprotein B | 4 months | |
| Secondary | Apo-B concentration in blood serum | Apolipoprotein B | 12 months | |
| Secondary | Apo-B concentration in blood serum | Apolipoprotein B | 18 months | |
| Secondary | NT-ProBNP concentration in plasma | N-Terminal Brain Natriuretic Peptide | 4 months | |
| Secondary | NT-ProBNP concentration in plasma | N-Terminal Brain Natriuretic Peptide | 12 months | |
| Secondary | NT-ProBNP concentration in plasma | N-Terminal Brain Natriuretic Peptide | 18 months | |
| Secondary | Lp(a) concentration in blood serum | Lipoprotein(a) | 4 months | |
| Secondary | Lp(a) concentration in blood serum | Lipoprotein(a) | 12 months | |
| Secondary | Lp(a) concentration in blood serum | Lipoprotein(a) | 18 months |
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