Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Blood Pressure
- Obesity
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 medicat...
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
Tracking Information
- NCT #
- NCT04575194
- Collaborators
- Athens Medical Center
- Investigators
- Principal Investigator: Alexandros Kokkinos, MD, PhD National and Kapodistrian University of Athens