Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
The aim of the present study is to compare the efficacy of liraglutide vs.
 naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as
 the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after
 a test meal. The study will include 40 patients, who will further be divided into two
 treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The
 patients will be examined at baseline, 3 and 6 months after the treatment initiation.
This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2
 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty
 infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2). Patients' data will be
 collected before starting medication (time 0) and at 3 and 6 months under treatment in the
 clinical practice of the selected drug, as described in the drug's package leaflet, along
 with a simultaneous dietary intervention and exercise. Patient groups will be comparable in
 age, gender and BMI.

 The aim of the study is the comparison of the efficacy of liraglutide vs.
 naltrexone/bupropion in metabolic and cardiovascular markers.

 The following parameters will be measured:

 -  Weight, height, waist and hip circumference

 -  24-hour recording of blood pressure and heart rate

 -  HbA1c, total cholesterol, LDL, HDL, urine albumin/creatinine ratio

 -  Bioelectric impedance for determination of total and visceral fat and muscle mass
 Indirect calorimetry for the determination of resting metabolic rate and total energy
 expenditure

 -  Determination of baroreflex sensitivity (BRS) and heart rate variability (HRV) to
 investigate the function of the autonomic nervous system

 -  Blood sample test meal at 0, 30, 60, 90, 120, 150 and 180 min to determine insulin
 concentration and gastrointestinal hormones involved in hunger and satiety with modern
 indirect calorimetry to determine postprandial thermogenic analog scales (VAS)

 -  Neuropathy tests

 -  Assessment of quality of life with the SF-36 questionnaire and assessment of the feeling
 of hunger and satiety

 -  Echocardiographic determination of the left systolic and telodiastolic diameter of the
 left ventricle, cardiac fat and the Tei index at times 0 and 6 months with medication

 -  Pericardial fat
Inclusion Criteria:

 -  Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of
 dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or
 prediabetes.

 Exclusion Criteria:

 1. Presence of any clinical contraindications for the administration of liraglutide or
 bupropion / naltrexone

 2. Bariatric surgery

 3. Diabetes type 2

 4. Active malignancy

 5. Medication that affects weight (eg corticosteroids, phenothiazines)