391/2025/OssF/AOUBo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients
研究概览
简要总结
The study is multicenter and observational, consisting of a cross-sectional phase (V0) in which data will be collected from patients who are offered drug therapy, and a prospective longitudinal phase in which only patients who agree to start drug therapy for obesity will be involved
详细描述
The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients to whom it is proposed.
The secondary objective will only concern patients who decide to start anti-obesity drug therapy. In this population, the efficacy and tolerance of these molecules and patient adherence to drug therapy in a real-life setting will be evaluated.
These parameters will be monitored with regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug.
The study population will consist of patients aged ≥ 12 years, the age at which certain therapies are approved for obesity (Liraglutide and Semaglutide in particular).
Patients will be recruited from among those who meet all inclusion and exclusion criteria and are followed up at the listed healthcare units or by the listed private practitioners.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years
- •Therapeutic indication for taking one of the following drugs for the treatment of obesity: Orlistat, Naltrexone/Bupropion (Mysimba®), Liraglutide (Saxenda®), Semaglutide (Wegovy®), Tirzepatide (Mounjaro®)
排除标准
- •Type 1 and type 2 diabetes mellitus
- •- Secondary forms of obesity:
- •Hypothalamic obesity (both monogenic and acquired forms);
- •Syndromic obesity (e.g., Prader-Willi, Alstrom, Bardet Biedl, etc.);
- •Endocrinopathies associated with obesity (Cushing's syndrome, uncompensated hypothyroidism)
结局指标
主要结局
The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients
时间窗: 10 years
The primary objective is to identify the proportion and medical history, social, clinical, laboratory, and behavioral characteristics of patients who accept a prescription for a drug for overweight and obesity compared to the total number of patients to whom it is proposed. These parameters will be monitored with regular follow-ups for up to 5 years after the start of therapy or 12 months after discontinuation of the drug. Descriptive statistics will be used to verify the primary objective. The demographic and clinical characteristics of patients will be reported as frequencies and percentages for categorical variables and as mean ± standard deviation or median and range for continuous variables.
次要结局
- The secondary objective will only concern patients who decide to start anti-obesity drug therapy. In this population, the efficacy and tolerance of these molecules and patient adherence to drug therapy in a real-life setting will be evaluated(10 years)
- descriptive statistics, paired t-tests, Wilcoxon signed-rank tests, McNemar tests, t-tests, Kruskal-Wallis tests, chi-square tests, Fisher's exact tests, logistic regression models, conditional logistic regression, linear mixed-effects models(10 years)
研究者
Uberto Pagotto
Medical Doctor, Head of Endocrinology, full professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna