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Evaluation of the effectiveness and safety of metabolic surgery for obesity: a clinical cohort study

Evaluation of the effectiveness and safety of metabolic surgery for obesity: a clinical cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028513
Enrollment
Unknown
Registered
2019-12-24
Start date
2011-02-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Case series:Metabolic surgery

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Indications for surgery for patients with simple obesity: 1. Body mass index (BMI) >=37.5 kg / m2, surgery is strongly recommended; BMI 32.5 kg/m2 to 37.5 kg/m2, recommended surgery; BMI 27.5 to 32.5 kg/m2, which is difficult to control after lifestyle changes and medical treatment, and which meets at least 2 MetS components, or has comorbidities, surgery can be considered after comprehensive evaluation; 2. Waist circumference >=90 cm in men and waist cm >=85 cm in women. Imaging examination indicates central obesity. After extensive consultation with the Multidisciplinary Therapy Cooperative Group (MDT), the level of surgical recommendation can be increased as appropriate; 3. Aged 16 to 65 years. Indications for surgery in T2DM patients: 1. T2DM patients still have some insulin secretion function; 2. BMI >=32.5 kg / m2,surgery is strongly recommended; BMI 27.5 to 32.5 kg/m2, recommended surgery; BMI 25 kg to 27.5 kg/m2, which is difficult to control blood glucose through lifestyle changes and medication, which meets at least 2 MetS components, or has comorbidities, perform surgery carefully; 3. For patients with BMI 25 to 27.5 kg/m2, waist circumference >=90 cm in men or waist circumference >=85 cm in women, and imaging examination suggest central obesity. After extensive consultation with MDT, the level of surgical recommendation can be increased as appropriate; 4. Aged 16 to 65 years. For patients over 65 years of age, they should actively consider their health status, comorbidities, and treatment, MDT discussions, fully evaluate cardiopulmonary function and surgical tolerance, and perform surgery with caution after informed consent.

Exclusion criteria

Exclusion criteria: 1. A confirmed diagnosis of non-obese type 1 diabetes; 2. Patients in purpose of treating T2DM with islet B cell function have basically lost; 3. For patients with a BMI <25.0kg / m2 , surgery is currently not recommended; 4. Patients with gestational diabetes and some special types of diabetes; 5. Drug abuse or alcohol addiction or suffering from uncontrollable mental illness; 6. People with intellectual disability or mental immature who cannot control themselves; 7. Those who do not expect actual for surgery; 8. Those who are unwilling to bear the risk of potential complications of surgery; 9. Those who cannot cooperate with changes in postoperative diet and living habits, and poor compliance; 10. Those with poor general conditions who cannot tolerate general anesthesia or surgery.

Design outcomes

Primary

MeasureTime frame
Obesity related parameters such as Weight';Adverse events and serious adverse events;

Countries

China

Contacts

Public ContactHaoyong Yu

Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital

yuhaoyong111@163.com+86 18930173807

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026