Chinese Registry of Overweight or Obesity, a Multicenter Real-World Registry Study on Clinical Management - CROWN Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- The treatment model for overweight and obese individuals in China at present.
研究概览
简要总结
This study will enroll 10,000 patients with obesity, with the participation of approximately 50 medical institutions nationwide. At baseline, demographic data, physical examinations, multiple laboratory tests (including complete blood count, urinalysis, liver/renal function, electrolytes, thyroid function panel [3 items], urine albumin/creatinine ratio, fasting glucose, fasting C-peptide, fasting insulin, HbA1c, blood lipids, etc.) and hepatic elasticity ultrasound will be performed. Patients will receive weight-loss therapy in routine clinical practice. Data on clinic visits, adverse events, and changes in therapeutic regimens will be centrally collected by investigators or their authorized representatives at Week 26 and Week 52.
详细描述
This is a prospective, multicenter registry study designed to investigate the clinical characteristics and prognosis of obese patients in China, which may provide insights and opportunities to narrow the gaps in obesity-related clinical practice and improve clinical practice standards in China. The study will recruit 10,000 subjects from weight management clinics or endocrinology departments of 50 tertiary or higher-level medical institutions nationwide and follow them up for one year.
Researchers will obtain informed consent for study participation from obese patients during routine clinical visits, after which patients will be enrolled and registered.
Subsequently, subjects will undergo a baseline visit and be invited to participate in this 1 year observational registry study. They will receive clinical evaluations and the treatment regimens prescribed by their treating physicians.
Following the scheduled baseline visit, subjects will continue to be followed up for 1 year through routine clinical care as part of this observational study, and all collected data will be uploaded to the registry center.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to local regulations, the subjects included in the study should meet the following criteria:
- •Male or female patients aged 18 years or above
- •Diagnosed with overweight or obesity, with a BMI of ≥ 24 kg/m²
- •Willing and able to use weight management apps
- •Willing and able to provide a written informed consent for participating in the study
- •Patients who meet the instructions for weight loss medication and have no contraindications to non-pharmacological treatments -
排除标准
- •Having life-threatening comorbidities, with an expected lifespan of less than one year.
- •Participating in an interventional trial that requires informed consent.
- •Engaging in other organized weight loss programs or other clinical trials.
- •Researchers identify any situation that may endanger the safety or compliance of the subjects.
结局指标
主要结局
The treatment model for overweight and obese individuals in China at present.
时间窗: 1 year
次要结局
- Observe the changes in liver fat content and liver stiffness in Chinese overweight and obese patients after 6 months and 12 months of follow-up: Liver stiffness measurement (LSM) and control attenuation index (Cap)(6 months and 12 months)
- Observe the changes in body weight after 6 months and 12 months of follow-up: BMI(6 months and 12 months)
- Evaluation of risk factors related to fatty liver disease in obesity combined with metabolic dysfunction(6 months and 12 months)
- Observe the changes in related metabolic indicators over 6 months and 12 months, including changes in indicators such as blood lipids, blood pressure, and blood sugar.(6 months and 12 months)
- Conduct a subset analysis for patients undergoing weight loss treatment with Mazdutide, analyzing related indicators including weight, metabolic indicators, cardiovascular and renal outcomes, and adverse reactions.(6 months and 12 months)
- Observe the social demographic and clinical characteristics of obese and overweight patients(6 months and 12 months)
- Observe the impact of different weight management methods on cardiovascular and renal outcomes and their risk factors.(6 months and 12 months)
研究者
Yiming Mu
Director, Head of the Endocrinology Department
Chinese PLA General Hospital