Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial.
Dag Hofsø, Farhat Fatima, Heidi Borgeraas...
https://pubmed.ncbi.nlm.nih.gov/31678062Actively Recruiting
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID05211375
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Led by Seoul National University Bundang Hospital · Updated on 2022-01-27
130
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
A
Ajou University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of two types of metabolic surgeries—sleeve gastrectomy (SG) with duodenojejunal bypass (DJB) and SG alone—on patients with type 2 diabetes mellitus (T2DM) who have poor blood sugar control despite current medical treatments but still retain some pancreatic beta-cell function. The study targets patients using insulin for less than 10 years or those taking diabetic medications with HbA1c levels of 7.0% or higher for less than 10 years. The goal is to compare which surgical approach provides better diabetes control in this group. In this randomized trial, one group will receive sleeve gastrectomy alone, where part of the stomach is surgically reduced using a bougie tube for guidance. The other group will undergo sleeve gastrectomy combined with duodenojejunal bypass, which involves rerouting the small intestine to bypass part of the duodenum and jejunum, potentially affecting nutrient absorption. Both surgical procedures are performed with specific technical details, such as the size and location of stapling and anastomosis. The study will follow participants for up to 10 years, assessing various health outcomes over time. Participants will be monitored for diabetes remission rates, hypertension and hyperlipidemia improvements, nutritional deficiencies, changes in body weight and composition, quality of life, and complications both early (within 30 days) and late (beyond 30 days) after surgery. Assessments will take place at multiple intervals, including 1, 3, 5, and 10 years after surgery. The study aims to provide long-term data on the metabolic effects and safety of these surgical options for T2DM treatment in Asian patients with moderate obesity.
CONDITIONS
Brief Title
Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Body mass index (BMI) equal to or greater than 27.5 kg/m2
- Type 2 diabetes duration of 10 years or less
- Using insulin, or HbA1c 7.0% or higher while taking diabetes medication
- C-peptide level higher than 1.0 ng/mL
- Presence of type 2 diabetes fulfilling the criteria
- Consent to avoid pregnancy for at least 1 year after surgery
- Willingness to provide voluntary informed consent
You will not qualify if you...
- Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more)
- History of previous metabolic surgery for type 2 diabetes
- History of gastrointestinal surgery affecting metabolic surgery results
- Using more than 3 psychiatric drugs due to poorly controlled psychiatric disorders
- Suicidal attempts within the last 12 months
- Treatment for alcohol or drug abuse within the last 12 months
- Vulnerability factors such as lack of mental capacity, pregnancy, planned pregnancy, or lactation
- Unsuitability as decided by the researcher
AI-Screening
AI-Powered Screening
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1
2
3
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 - Day of surgery plus immediate recovery period
Participants undergo either sleeve gastrectomy alone or sleeve gastrectomy with duodenojejunal bypass as surgical treatments for type 2 diabetes.
1 surgery visit and approximately 1 to 2 post-operative visits
Post-operative Follow-up
Duration - Up to 10 years after surgery
Participants are monitored for complications and metabolic outcomes after surgery, with assessments occurring over several years to evaluate diabetes remission and other health changes.
Follow-up visits at 1, 3, 5, and 10 years after surgery
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
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Research Team
Y
Young Suk Park
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
Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity.
Ali Aminian, Stacy A Brethauer, Amin Andalib...
https://pubmed.ncbi.nlm.nih.gov/28742680Standardized outcomes reporting in metabolic and bariatric surgery.
Stacy A Brethauer, Julie Kim, Maher el Chaar...
https://pubmed.ncbi.nlm.nih.gov/26093765