Chinese, Overweight or Obesity, Real-World Registry Study

N/ANot Yet RecruitingNCT07525037

Chinese PLA General Hospital10,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Obesity Type 2 Diabetes Mellitus

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: According to local regulations, the subjects included in the study should meet the following criteria: 1. Male or female patients aged 18 years or above 2. Diagnosed with overweight or obesity, with a BMI of ≥ 24 kg/m² 3. Willing and able to use weight management apps 4. Willing and able to provide a written informed consent for participating in the study 5. Patients who meet the instructions for weight loss medication and have no contraindications to non-pharmacological treatments - Exclusion Criteria: 1. Having life-threatening comorbidities, with an expected lifespan of less than one year. 2. Participating in an interventional trial that requires informed consent. 3. Engaging in other organized weight loss programs or other clinical trials. 4. Researchers identify any situation that may endanger the safety or compliance of the subjects. \-

Outcomes

Primary Outcomes

The treatment model for overweight and obese individuals in China at present.

Time frame: 1 year

Secondary Outcomes

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)