Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05015283

Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission (ORDER): a Multi-center, Randomized, Open-label Trial

Led by Beijing Friendship Hospital · Updated on 2022-08-03

248

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

B

Beijing Friendship Hospital

Lead Sponsor

B

Beijing Tiantan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two types of metabolic surgery for people with obesity complicated by type 2 diabetes mellitus (T2DM). The study compares one-anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB), both known surgical treatments for weight loss and metabolic improvement. This multi-center, randomized, open-label trial aims to generate high-level evidence on the effectiveness and safety of these surgeries in Asian patients, focusing mainly on diabetes remission rates. Participants will be randomly assigned to receive either laparoscopic OAGB or laparoscopic RYGB, each performed according to a standard procedure. OAGB involves a specific gastrointestinal anastomosis with defined limb lengths, while RYGB uses a different stomach pouch size and limb configuration. The surgeries will be followed up over five years, with a target to keep follow-up loss under 20% and maintain data completeness above 95%. During the study, participants will undergo regular assessments including blood glucose monitoring, HbA1c measurements, weight loss tracking, and evaluation of diabetes medication usage. Other outcomes include surgery time, hospital stay length, quality of life questionnaires, and monitoring for surgical complications and symptoms like gastroesophageal reflux and dumping syndrome. The primary outcome is the complete remission rate of T2DM one year after surgery, with additional long-term measures collected over five years.

CONDITIONS

Brief Title

Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 21 to 65 years, male or female, East Asian population
  • Body mass index (BMI) between 27.5 and 50 kg/m2
  • Diagnosed with type 2 diabetes for at least 6 months
  • HbA1c of 7.0% or higher
  • Currently taking one or more diabetes medications, including insulin or GLP-1 receptor agonists
  • Recommended for one-anastomosis gastric bypass or Roux-en-Y gastric bypass by a multidisciplinary team
Not Eligible

You will not qualify if you...

  • Previous gastrointestinal or bariatric surgery
  • Fasting C-peptide level less than half the normal minimum
  • Active gastrointestinal ulcers
  • Helicobacter pylori infection
  • History of serious heart or brain blood vessel diseases such as heart attack or stroke
  • History of cirrhosis (Child-Pugh class A or worse)
  • Chronic kidney disease with eGFR below 60 ml/min/1.73 m2
  • Presence of inflammatory bowel disease like ulcerative colitis or Crohn's disease
  • Chronic anemia (hemoglobin below 100 g/L in males or below 90 g/L in females)
  • Planning to become pregnant during the study period
  • Uncontrolled mental or psychological disorders
  • Expected survival less than 5 years due to end-stage disease or cancer
  • Participation in other clinical trials conflicting with this study
  • Unable to understand or unwilling to sign informed consent
  • Gallstones requiring gallbladder removal
  • Reflux esophagitis above grade A

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day (Day 0) through hospital stay of approximately 30 days

Participants undergo either laparoscopic one-anastomosis gastric bypass or laparoscopic Roux-en-Y gastric bypass surgery following standard procedures, with immediate post-operative care.

Hospital stay from surgery day up to 30 days

Post-operative Follow-up

Duration - Up to 5 years after surgery

Participants are monitored for diabetes remission, weight loss, and surgical outcomes including complications and quality of life after surgery.

Periodic visits over 5 years including assessments at 1 year and 5 years post-surgery

Trial Site Locations

Total: 1 location

1

Beijing Friendship Hospital

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

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Research Team

Z

Zhongtao Zhang, M.D.;Ph.D

M

Mengyi Li, M.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial.

Mengyi Li, Yang Liu, Wei-Jei Lee...

https://pubmed.ncbi.nlm.nih.gov/36175102