NCT04575194

Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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 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

Conditions

• Obesity
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Liraglutide 6 MG/ML [Saxenda]	3 mg of sc liraglutide daily plus lifestyle intervention
DRUG	Naltrexone-Bupropion Combination	32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-09-30
• Completion: 2023-05-30
• First posted: 2020-10-05
• Last updated: 2020-10-08

Locations

1 site across 1 country: Greece