Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

NCT ID: NCT04575194

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2023-05-30

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

Conditions

Obesity; Blood Pressure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide 3 mg

Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention.

Group Type: ACTIVE_COMPARATOR

Liraglutide 6 MG/ML [Saxenda]

Intervention Type: DRUG

3 mg of sc liraglutide daily plus lifestyle intervention

Naltrexone/bupropion 32/360 mg

Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention.

Group Type: ACTIVE_COMPARATOR

Naltrexone-Bupropion Combination

Intervention Type: DRUG

32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention

Interventions

Liraglutide 6 MG/ML [Saxenda]

3 mg of sc liraglutide daily plus lifestyle intervention

Intervention Type: DRUG

Naltrexone-Bupropion Combination

32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Athens Medical Center

OTHER

Sponsor Role: collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Alexandros Kokkinos

Associate Professor in Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandros Kokkinos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

First Department of Propaedeutic Internal Medicine

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Alexandros Kokkinos, MD, PhD

Role: CONTACT

rjd@otenet.gr

+302132061248

Georgia Argyrakopoulou, MD, PhD, MSc

Role: CONTACT

gargyrakopoulou@gmail.com

+306972284033

Facility Contacts

Alexandros Kokkinos, MD, PhD

Role: primary

rjd@otenet.gr

2132061248

References

Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28.

Reference Type: DERIVED

PMID: 37418844 (View on PubMed)

Other Identifiers

Obesity drugs study

Identifier Type: -

Identifier Source: org_study_id