GLP1 Agonists Once Weekly for the Treatment of Obesity in Patients With Bardet-Biedl Syndrome (BBS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to learn about the long-term effects of GLP1 agonists (weight loss jab, including Mounjaro) in patients with Bardet-Biedl Syndrome (BBS) who take GLP1 agonists to treat high body weight. The main question:
Do GLP1 agonists effectively and safely lower body weight in patients with BBS when taken long-term, compared to patients not on these medications? The investigators look at the change (%) in weight during the observational periods.
详细描述
Demographics on time zero: Age, gender, Race, Body Weight (BW), Body Mass Index (BMI), Blood Pressure (clinic, DM meds), Pulse, Lipid profiles (Chol, HDL, LDL, TG), eGFR, HBA1c, (if feasible) genetic diagnosis
Primary outcome at the end of study date : Body weight change (%)
Secondary outcome at the end of study date: change in lipid (Chol, HDL, LDL, TG), Blood Pressure, DM status
Quality assurance plan: data validation will be secured due to the electronic record. The registry process was undertaken in our closed national BBS centres quality assured by multi-disciplinary team (MDT) looked after by senior specialty nurses, who followed all the patients with GLP1 agonists monthly over the telephone.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK).
排除标准
- •Adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK) who lost follow ups or significant missing data, or BMI<30 in patients without GLP1 agonists.
研究者
Yuki Heath
Specialty Doctor in Renal Medicine
The Queen Elizabeth Hospital