Obesity Type 2 Diabetes Mellitus
Conditions
Keywords
Real world study, Obesity Type 2 Diabetes Mellitus
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Chinese PLA General Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment model for overweight and obese individuals in China at present. | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1. Describe different social demographic characteristics (age, gender, race, education level, marital status, family history, physical activity, smoking history, alcohol consumption. 2. Describe different clinical characteristics (body mass index \[BMI\], body fat percentage, waist circumference, waist-to-hip ratio, waist-to-height ratio, duration of obesity, duration of fatty liver disease, the number, type, and prevalence of other obesity-related comorbidities: especially non-alcoholic fatty liver disease, polycystic ovary syndrome, sleep apnea syndrome, etc.) 3. Compare the differences in demographic and clinical characteristics among different groups of patients with different regions, different degrees of obesity, etc. |
| Observe the impact of different weight management methods on cardiovascular and renal outcomes and their risk factors. | 6 months and 12 months | 1. Observe the changes in weight-related indicators and metabolic-related 2. Compare the differences in cardiovascular and renal outcomes among different populations. |
Countries
China
Contacts
CONTACTMuYiming
CONTACTChenKang
Outcome results
None listed