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Clinical Efficacy of Gastric Bypass Stent System in Treating Obesity with Metabolic Diseases and the Role of a Standardized Comprehensive Intervention Management Model in Long-term Control

Clinical Efficacy of Gastric Bypass Stent System in Treating Obesity with Metabolic Diseases and the Role of a Standardized Comprehensive Intervention Management Model in Long-term Control

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107998
Enrollment
Unknown
Registered
2025-08-22
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Obesity and related metabolic diseases

Interventions

Gastric Bypass Stent Implantation Group:None

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The following patients who are ineffective in lifestyle modification and have poor response to non-invasive treatment and drug treatment: BMI>=30.0 and two or more metabolic syndrome components, namely: (1) abdominal obesity (waist circumference >=90 cm for men, >=85 cm for women) (2) hyperglycemia (fasting blood glucose >=6.1 mmol/L or 2-hour postprandial blood glucose >=7.8 mmol/L, or diagnosed diabetes mellitus and receiving treatment) (3) hypertension (blood pressure>=130/85). mmHg or confirmed hypertension and treated) (4) fasting triglycerides (TG) >=1.70 mmol/L, or fasting high-density lipoprotein cholesterol (HDL-C) =32.5 and two or more of the following comorbidities: non-alcoholic fatty liver disease, abnormal glucose and lipid metabolism, hyperuricemia, hypertension, atherosclerosis, polycystic ovary syndrome, obstructive sleep apnea, gastroesophageal reflux, insulin resistance.

Exclusion criteria

Exclusion criteria: 1. Those who have taken antiplatelet drugs or anticoagulant drugs such as aspirin in the past month; Patients with basic loss of pancreatic islet ß cell function, C-peptide 2.5 times, total bilirubin > 35, serum creatinine concentration greater than 180 µmol/L; Definitive diagnosis of type 1 diabetes; Patients with ASA greater than or equal to grade III.; Drug or alcohol abuse addiction or suffering from uncontrollable mental illness; Duodenal bulb ulcer, gastric ulcer or previous and existing pancreatitis; Coronary heart disease, angina, cardiac function grade III or above, or pulmonary dysfunction; Patients who have undergone ERCP surgery; Patients with potential bleeding or telangiectasia in the stomach, esophagus, small intestine and other parts; Have a history of systemic lupus erythematosus, scleroderma; Those who have contraindications to endoscopy (judged by clinicians); Pregnant women or those who are preparing to become pregnant; Those who are allergic to nickel-titanium; Any other situation that the clinician deems inappropriate for participation in this product.

Design outcomes

Primary

MeasureTime frame
Percentage reduction in BMI from baseline;

Countries

China

Contacts

Public Contactfupeng

Shandong Provincial Third Hospital

garuda1981@163.com+86 531 81656762

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026