Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

Obesity Clinical Trial

Official title:

Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575194
• Other study ID #: Obesity drugs study
• Status: Recruiting
• Phase: Phase 4
• Start date: September 8, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2020
• Source: National and Kapodistrian University of Athens
• Contact: Alexandros Kokkinos, MD, PhD
• Phone: +302132061248
• Email: rjd[@]otenet.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure
• Obesity

Intervention

Drug:
• Liraglutide 6 MG/ML [Saxenda]
3 mg of sc liraglutide daily plus lifestyle intervention
• Naltrexone-Bupropion Combination
32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention

Locations

Country	Name	City	State
Greece	First Department of Propaedeutic Internal Medicine	Athens

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Athens Medical Center

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood pressure	Blood pressure as assessed by 24-hour recording (numerical scale)	3 and 6 months
Secondary	Weight loss	Percentage of weight lost will be measured by an electronic scale (numerical scale)	3 and 6 months
Secondary	Changes in glycemic	Measurement of HbA1c will be measured biochemically (numerical scale)	3 and 6 months
Secondary	Changes in lipemic profile	Total cholesterol, Triglycerides, LDL-C, HDL-C will be measured biochemically (numerical scale)	3 and 6 months
Secondary	Percentage of visceral fat	Measurement of visceral fat by bioimpedance analysis (numerical scale)	3 and 6 months
Secondary	Fat mass	Measurement of fat mass by bioimpedance analysis (numerical scale)	3 and 6 months
Secondary	Fat free mass	Measurement of fat free mass by bioimpedance analysis (numerical scale)	3 and 6 months
Secondary	Autonomic nervous system function	Measurement of heart rate variability will be measured through Ewing score and Spectral analysis testing (numerical scale)	3 and 6 months
Secondary	Changes in meal induced thermogenesis	Measurement through indirect calorimetry and assessment of changes in Resting Metabolic Rate (RMR) (numerical scale)	3 and 6 months
Secondary	Changes in gut hormones involved in appetite regulation	Measurement in plasma before and after the intervention during a mixed meal test will be measured through ELISA kits (numerical scale)	3 and 6 months