Duodenal-Ileal Diversion + Sleeve Gastrectomy for Obesity and Type 2 Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that your diabetes medications should be oral and your HbA1c levels must be stable, so it's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Duodenal-Ileal Diversion With a Sleeve Gastrectomy for obesity and type 2 diabetes?
Is the Duodenal-Ileal Diversion with Sleeve Gastrectomy safe for humans?
The Duodenal-Ileal Diversion with Sleeve Gastrectomy, also known as SADI-S, is considered safe based on current studies, but there is a need for more long-term data and high-level evidence. International medical societies recommend enrolling patients in registries and conducting more studies to better understand its safety over time.35678
How is the treatment Duodenal-Ileal Diversion With a Sleeve Gastrectomy different from other treatments for obesity and type 2 diabetes?
This treatment combines a sleeve gastrectomy (removal of part of the stomach) with a duodenal-ileal diversion, which not only restricts food intake but also alters the digestive process to improve blood sugar control. Unlike standard medical treatments, it targets both weight loss and diabetes remission by changing how the body absorbs nutrients.12359
What is the purpose of this trial?
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
Eligibility Criteria
This trial is for adults aged 19-65 with obesity (BMI between 35 and 50) and type 2 diabetes diagnosed within the last decade. Participants must have stable weight, controlled related health issues like hypertension, and not be on insulin or planning pregnancy. They should commit to no other weight-affecting surgeries for two years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Self-Forming Magnet (SFM) System procedure to create a duodenal-ileal diversion followed by a sleeve gastrectomy
Follow-up
Participants are monitored for weight loss and metabolic indicators, including changes in serum lipids, diabetes medication dosage, blood pressure, liver changes, fasting glucose, diabetes remission, albumin levels, and weight loss measures
Treatment Details
Interventions
- Duodenal-Ileal Diversion With a Sleeve Gastrectomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
GI Windows, Inc.
Lead Sponsor