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A randomized controlled trial for loop versus Roux-en-Y duodenojejunal bypass with sleeve gastrectomy in the treatment of type 2 diabetes mellitus with obesity

A randomized controlled trial for loop versus Roux-en-Y duodenojejunal bypass with sleeve gastrectomy in the treatment of type 2 diabetes mellitus with obesity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033443
Enrollment
Unknown
Registered
2020-06-01
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

type 2 diabetes mellitus with obesity

Interventions

loop anastomosis group:receiving loop sleeve gastrectomy combined with duodenaljejunal bypass
Roux-en-Y anastomosis group:receiving Roux-en-Y sleeve gastrectomy combined with duodenaljejunal bypass

Sponsors

The First Affliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patient with T2DM aged 20 to 60 years old, the duration of disease less than 15 years, and the fasting C peptide level is greater than the minimum reference value, and meets one of the following conditions: 1. T2DM patients with BMI>=32.5 and poor control of blood glucose (HbA1c> 7.0%), who are managed by the diet control of the nutrition department, other life styles and optimized medical control regulated by the endocrinology department for more than half a year; 2. T2DM patients with BMI 27.5 to 32.5, poor control of blood glucose (HbA1c> 7.0%) and other cardiovascular risk factors such as high TG and low HDL -C, high blood pressure, or those with diabetes complications, who are managed by the diet control of the nutrition department, other life styles and optimized medical control regulated by the endocrinology department for more than half a year.

Exclusion criteria

Exclusion criteria: 1. T1DM, LADA, gestational diabetes and other special types of diabetes; 2. Preoperative diagnosis of GERD; 3. Drug or alcohol addiction or suffering from uncontrollable mental illness; 4. Those with intellectual disability or immature treatment, whose behavior cannot be controlled; 5. Those who have unrealistic anticipation of the surgery; 6. Unwilling to bear the risk of potential complications of surgery; 7. Those who can not cooperate with postoperative diet and lifestyle changes, and have poor compliance; 8. Those who have poor general condition and are unable to tolerate general anesthesia or surgery; 9. Disagree with participants.

Design outcomes

Primary

MeasureTime frame
remission rate of type 2 diebetes mellitus;

Countries

China

Contacts

Public ContactHui Liang

The First Affliated Hospital of Nanjing Medical University

drhuiliang@126.com+86 13951601358

Outcome results

None listed

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