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Randomized, controlled, trial for effectiveness and complications of two metabolic surgical procedures in Chinese obese patients with type 2 diabetes mellitus

Randomized, controlled, trial for effectiveness and complications of two metabolic surgical procedures in Chinese obese patients with type 2 diabetes mellitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016455
Enrollment
Unknown
Registered
2018-06-02
Start date
2018-06-02
Completion date
Unknown
Last updated
2018-06-05

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

Conditions

Type 2 diabetes

Interventions

Group SG:Sleeve gastrectomy
Group RYGB:Gastric bypass surgery

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years when signing the Informed Consent Form (ICD); 2. The body mass index (BMI) is 30kg/m2 to 35kg/m2 (including 30kg/m2 and 35kg/m2); 3. According to WHO standards, T2DM has been diagnosed in the past for at least 6 months; 4. C peptides> 1ng/mL (0.3 nmol/L); 5. Willing and able to comply with the research process of the program; 6. Can understand and sign the study informed consent, if it is illiterate, willing to handprint on the informed consent.

Exclusion criteria

Exclusion criteria: 1. The history of T2DM lasts more than 15 years; 2. History of drug and/or alcohol abuse within 2 years before the screening visit; 3. Have had any major gastrointestinal surgery (eg, any gastrointestinal surgery for resection). History of previous gastrointestinal surgeries is allowed: appendectomy, cholecystectomy, liver biopsy, and endoscopic surgery; 4. Women of childbearing age who are pregnant or lactating during screening or surgery, or plan to become pregnant within one year after surgery; 5. Mental illnesses that may affect clinical research compliance, including dementia, active psychosis, major depression, or attempted suicide; 6. meets any of the following conditions: (1) Inflammatory diseases of the gastrointestinal tract, including severe refractory esophagitis, gastric ulcer, duodenal ulcer, or specific inflammation that has been active during the past 10 years, such as Crohn's disease or ulcerative colitis; (2) End-stage renal disease; (3) Abnormality of glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A); or (4) Poor immune function, for example caused by long-term oral steroids, cancer chemotherapy drugs, or immunodeficiency diseases; 7. Participate in any other clinical studies (other than registration or survey studies) within 30 days of visit 1 (screening visit) or during the study.

Design outcomes

Primary

MeasureTime frame
Incidence of comprehensive measurement of blood glucose control;

Secondary

MeasureTime frame
Adverse events and serious adverse events;Obesity related parameters such as “Weight”;Medication;

Countries

China

Contacts

Public ContactYuqian Bao
byq522@163.com+86 18930172033

Outcome results

None listed

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