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Morbid obesity treatment by SADI-S: a multi-center randomized controlled clinical trial

Morbid obesity treatment by SADI-S: a multi-center randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036266
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

Morbid obesity

Interventions

Group of SADI-S:SADI-S Surgery
Group of SG:SG Surgery

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1)Aged 18 to 60 years; 2)Body mass index (BMI) >= 37.5 kg / m2; 3) Willing and able to comply with the research procedures stipulated in the protocol; and 4) Able to understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) The medical history of T2DM lasts more than 15 years; 2) A history of drug and/or alcohol abuse within 2 years before the screening visit; 3) Have previously received any major gastrointestinal surgery (for example, any gastrointestinal surgery for resection, etc.). Allow history of past gastrointestinal surgery including: appendectomy, cholecystectomy, liver biopsy and endoscopic surgery; 4) Women of childbearing age who are pregnant or breastfeeding during screening and surgery, or plan to become pregnant within one year after surgery; 5) Mental diseases that may affect compliance with clinical research, including dementia, active psychosis, severe depression, or attempted suicide; 6) Inflammatory diseases of the gastrointestinal tract, including severe refractory esophagitis, gastric ulcer, duodenal ulcer, or specific inflammation that has been active in the past 10 years, such as Crohn's disease or ulcerative colitis; 7) End-stage renal disease, glomerular filtration rate <15ml/min/1.73m2; 8) Glutamate decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A) is abnormal; 9) Immune function is low, such as caused by long-term oral steroid hormones, cancer chemotherapy drugs, or immunodeficiency diseases; 10) Participate in any other clinical research (except registration or investigative research) within 30 days before Visit 1 (screening visit), or during the research process.

Design outcomes

Primary

MeasureTime frame
%TWL;

Secondary

MeasureTime frame
Fasting Plasma Glucose;HbA1c;LDL-c;Blood pressure;Waist Circumstance;

Countries

China

Contacts

Public ContactBao Yuqian

Shanghai 6th People's Hospital

byq522@163.com+86 13788971763

Outcome results

None listed

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