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Compares treatment options for Type2 Diabetes
Official title Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission
ClinicalTrials.gov ID: NCT05015283
What this study is testing
- What it's testing
- Diabetes mellitus (T2DM) is the most common complication of obesity patients. According to previous literature reports, weight loss and metabolic surgery are powerful means to treat obesity complicated with T2DM.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 21-65 years old, Male/Female, East Asian population
- 50 kg/m2≥BMI≥27.5kg/m2
- Type 2 diabetes duration ≥6 months
- HbA1c≥7.0%
- Currently receiving one or more oral/injectable hypoglycemic drugs (insulin /glucagon-like peptide-1 receptor agonist)
You likely can't join if
- Underwent gastrointestinal surgery (gastric/duodenal surgery or bariatric surgery)
- Fasting C-peptide level lower than 1/2 normal minimum
- Active gastrointestinal ulcer is present
- Helicobacter pylori infection is present
- A history of serious cardiovascular and cerebrovascular diseases (myocardial infarction, stroke, etc.)
- A history of cirrhosis (Child-Pugh≥A)
See the full eligibility criteria
- 21-65 years old, Male/Female, East Asian population
- 50 kg/m2≥BMI≥27.5kg/m2
- Type 2 diabetes duration ≥6 months
- HbA1c≥7.0%
- Currently receiving one or more oral/injectable hypoglycemic drugs (insulin /glucagon-like peptide-1 receptor agonist)
- Recommendation for OAGB/RYGB evaluated by a multidisciplinary team
- Underwent gastrointestinal surgery (gastric/duodenal surgery or bariatric surgery)
- Fasting C-peptide level lower than 1/2 normal minimum
- Active gastrointestinal ulcer is present
- Helicobacter pylori infection is present
- A history of serious cardiovascular and cerebrovascular diseases (myocardial infarction, stroke, etc.)
- A history of cirrhosis (Child-Pugh≥A)
- A history of chronic kidney disease (eGFR )\< 60 ml/min / 1.73 m2)
- Inflammatory bowel disease is present (ulcerative colitis, Crohn's disease)
- Chronic anemia is present, Hgb for male \<100g/L, for female \<90g/L
- A desire to conception during the study period
- Uncontrolled mental and psychological disorders are present
- Expected survival\<5 years of end-stage disease or previous/current malignant tumor
- Participated in clinical studies/trials that have the conflict of interest with the study
- Unable to understand, refuse to participate and sign the informed consent
- Gallstones require cholecystectomy
- Reflux esophagitis above grade A
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.