The Effect of Mediterranean or High Protein/Low Carbohydrate Diet on Arterial Stiffness in Non-diabetic, Obese Patients on Semaglutide: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
研究概览
简要总结
In patients initiating Semaglutide for weight management, the objective is to compare the effect of the Mediterranean diet and the high protein/low carbohydrate (HP/LC) diet CV parameters, namely arterial stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), and visceral adipose tissue, in addition to other metabolic indicators.
详细描述
This is a 6-month open label pilot RCT that will be conducted on Lebanese subjects with obesity, upon the initiation of Semaglutide for medical weight management, as recommended by their physician. Patients will be randomized to 2 treatment arms: Med diet and HP/LC diet. Med diet will be hypocaloric, allowing the same energy restriction, of 500 Kcal/d, while the HP/LC diet will be ad libitum. Participants will be recruited from the Endocrine clinics at AUB-MC, and from satellite clinic next in Beirut. Brochures and posters of the trial will be available in the clinic waiting areas. Patients of both participating and non-participating physicians will be recruited in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The design is open label as it is impossible to blind the participants and the research team for the study intervention. Each of the dietary interventions will be delivered in the format of intensive individual sessions about the diet, food selection and food recipes. Outcome assessors will be blind to the intervention
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and premenopausal women, 18-49 years, with obesity defined as BMI ≥ 30 kg/m2
- •Upon the initiation of Semaglutide (within the first 1-4 weeks) for medical weight management, for clinical purposes, as advised by the primary physician
- •Able to commit for a 6-month trial visits
排除标准
- •Pregnant women
- •Patients who are taking or have taken other weight reducing drug therapies in the previous 6 months
- •Patients who have undergone metabolic weight loss surgery
- •Patients known to have diabetes (HbA1c ≥6.5% at screening)
- •Patients with uncontrolled hypertension
- •Patients with uncontrolled cardiac disease, pulmonary, renal or liver diseases, active cancer or psychiatric diseases
- •Patients with excessive alcohol intake, defined as ≥ 2 glasses per day
- •Patients known to have uncontrolled/ untreated thyroid disorders.
- •Patients with cushing disease or polycystic ovaries, and those with neuro-endocrine or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy): Such patients are resistant to weight loss, and they need treatment of their primary disease and/or cessation of the culprit medication to lose weight
- •Patients with untreated gout
- •Patients who have undergone bariatric surgery
结局指标
主要结局
cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
时间窗: 6 months after enrollment
Measured by an RA or a technician, based on the American Heart Association Council recommendations on arterial stiffness measurement in research. The distance from the suprasternal notch to the carotid pulse, and to the femoral site on the same side will be measured; the former distance is subtracted from the latter one. Ten seconds of carotid and 10 seconds of femoral arterial waveforms will be recorded, and the average of the data will be obtained for each of the sites.
次要结局
- Body composition - percent body fat using dual x-ray absorptiometry (DXA)(6 months after enrollment)
- Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)(6 months after enrollment)
- Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)(6 months after enrollment)
研究者
Marlene Chakhtoura
Assistant Professor of Medicine
American University of Beirut Medical Center