Clinical trial NCT04575194: Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
Official title: Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Blood Pressure
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Athens Medical Center
First posted: 2020-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in blood pressure
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Weight loss
timeFrame: 3 and 6 months
measure: Changes in glycemic
timeFrame: 3 and 6 months
measure: Changes in lipemic profile
timeFrame: 3 and 6 months
measure: Percentage of visceral fat
timeFrame: 3 and 6 months
measure: Fat mass
timeFrame: 3 and 6 months
measure: Fat free mass
timeFrame: 3 and 6 months
measure: Autonomic nervous system function
timeFrame: 3 and 6 months
measure: Changes in meal induced thermogenesis
timeFrame: 3 and 6 months
measure: Changes in gut hormones involved in appetite regulation
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Propaedeutic Internal Medicine
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Alexandros Kokkinos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: