Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in blood pressure
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone
- •Bariatric surgery
- •Diabetes type 2
- •Active malignancy
- •Medication that affects weight (eg corticosteroids, phenothiazines)
研究组 & 干预措施
Liraglutide 3 mg
Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention.
干预措施: Liraglutide 6 MG/ML [Saxenda] (Drug)
Naltrexone/bupropion 32/360 mg
Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention.
干预措施: Naltrexone-Bupropion Combination (Drug)
结局指标
主要结局
Changes in blood pressure
时间窗: 3 and 6 months
Blood pressure as assessed by 24-hour recording (numerical scale)
次要结局
- Changes in lipemic profile(3 and 6 months)
- Percentage of visceral fat(3 and 6 months)
- Fat mass(3 and 6 months)
- Fat free mass(3 and 6 months)
- Autonomic nervous system function(3 and 6 months)
- Changes in meal induced thermogenesis(3 and 6 months)
- Weight loss(3 and 6 months)
- Changes in glycemic(3 and 6 months)
- Changes in gut hormones involved in appetite regulation(3 and 6 months)
研究者
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens