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| Name | Class |
|---|---|
| Athens Medical Center | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 3 mg | Active Comparator | Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention. |
|
| Naltrexone/bupropion 32/360 mg | Active Comparator | Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide 6 MG/ML [Saxenda] | Drug | 3 mg of sc liraglutide daily plus lifestyle intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood pressure | Blood pressure as assessed by 24-hour recording (numerical scale) | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Percentage of weight lost will be measured by an electronic scale (numerical scale) | 3 and 6 months |
| Changes in glycemic | Measurement of HbA1c will be measured biochemically (numerical scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandros Kokkinos, MD, PhD | Contact | +302132061248 | rjd@otenet.gr | |
| Georgia Argyrakopoulou, MD, PhD, MSc | Contact | +306972284033 | gargyrakopoulou@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandros Kokkinos, MD, PhD | National and Kapodistrian University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Department of Propaedeutic Internal Medicine | Recruiting | Athens | 11527 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37418844 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| C000621664 | Naltrexone-Bupropion combination |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Naltrexone-Bupropion Combination | Drug | 32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention |
|
| 3 and 6 months |
| Changes in lipemic profile | Total cholesterol, Triglycerides, LDL-C, HDL-C will be measured biochemically (numerical scale) | 3 and 6 months |
| Percentage of visceral fat | Measurement of visceral fat by bioimpedance analysis (numerical scale) | 3 and 6 months |
| Fat mass | Measurement of fat mass by bioimpedance analysis (numerical scale) | 3 and 6 months |
| Fat free mass | Measurement of fat free mass by bioimpedance analysis (numerical scale) | 3 and 6 months |
| 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 |
| Changes in meal induced thermogenesis | Measurement through indirect calorimetry and assessment of changes in Resting Metabolic Rate (RMR) (numerical scale) | 3 and 6 months |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |