Duodenal-Ileal Diversion + Sleeve Gastrectomy for Obesity and Type 2 Diabetes

No longer recruiting at 2 trial locations

Overseen By Peter J Lukin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GI Windows, Inc.

Must be taking: Oral diabetes medications

Must not be taking: Injectable insulin

Disqualifiers: Type 1 diabetes, Uncontrolled hypertension, Severe cardio-respiratory disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Procedure duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new surgical approach to help individuals with obesity and type 2 diabetes manage their weight and improve their health. The treatment combines two procedures: a duodenal-ileal diversion and a sleeve gastrectomy, which together alter how the body processes food. Participants should have had type 2 diabetes for at least six months and be on oral diabetes medications, with stable blood sugar levels and weight over the past three months. Participants must avoid other weight-loss surgeries for two years. This trial may suit those dealing with obesity and diabetes who seek new treatment options. As an unphased trial, this study offers a unique opportunity for patients to explore innovative surgical treatments.

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 prior data suggests that this device is safe for creating a duodenal-ileal diversion?

Research has shown that combining duodenal-ileal diversion and sleeve gastrectomy, often called SADI-S, is generally safe. This procedure helps individuals lose significant weight, with patients losing an average of 67% to 114% of their excess weight within two years.

Regarding safety, studies indicate that most individuals tolerate this treatment well, and serious side effects are uncommon. However, as with any surgery, risks such as infection or anesthesia-related issues exist. Discussing these risks with a doctor is important to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the duodenal-ileal diversion combined with sleeve gastrectomy because it offers a new surgical approach for treating obesity and type 2 diabetes. Unlike standard treatments like gastric bypass or adjustable gastric bands, this procedure uses a Self-Forming Magnet (SFM) System to create a duodenal-ileal diversion. This innovative technique reroutes food away from the upper part of the small intestine, possibly enhancing weight loss and diabetes control more effectively. Additionally, the combination with sleeve gastrectomy can further aid in reducing stomach size, potentially improving metabolic outcomes.

What evidence suggests that this treatment might be an effective treatment for obesity and type 2 diabetes?

Research has shown that combining duodenal-ileal diversion with sleeve gastrectomy is highly effective for weight loss. In this trial, participants will use the Self-Forming Magnet (SFM) System to create a duodenal-ileal diversion, followed by a sleeve gastrectomy. Studies have found that individuals can lose between 67% and 114% of their excess weight within two years after undergoing this surgery. This treatment also aids in managing type 2 diabetes by improving the body's food processing. Most patients experience significant and lasting weight loss and health benefits. This method is simpler and quicker than traditional gastric bypass surgery because it involves only one intestinal connection. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

My obesity-related health issues like high blood pressure, cholesterol problems, or sleep apnea are under control.

I agree not to become pregnant for 24 months and will use birth control.

Your blood sugar levels must stay steady for 3 months.

Exclusion Criteria

I have a long-term stomach or intestine disease.

I have a serious heart or lung condition.

I use injectable insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Self-Forming Magnet (SFM) System procedure to create a duodenal-ileal diversion followed by a sleeve gastrectomy

Procedure duration not specified

1 visit (in-person for procedure)

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

12 months

Regular visits (frequency not specified)

What Are the Treatments Tested in This Trial?

Interventions

• Duodenal-Ileal Diversion With a Sleeve Gastrectomy

Trial Overview The study tests a Self Forming Magnetic Anastomosis System in a single group of participants across multiple centers. It aims to assess its effect on weight loss and metabolic changes in patients with obesity and type 2 diabetes.

How Is the Trial Designed?

Group I: Device Placement Experimental Treatment 1 Intervention

The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed.

Who Is Running the Clinical Trial?

GI Windows, Inc.

Lead Sponsor

Trials

9

Recruited

340+

Published Research Related to This Trial

In a study comparing single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) to Roux-en-Y gastric bypass (RYGB) in Chinese patients with diabetes and a BMI under 35 kg/m2, SADI-S resulted in significantly greater weight loss after 2 years (p = 0.017).

Both SADI-S and RYGB achieved similar rates of complete remission of type 2 diabetes (76.5% for SADI-S and 82.4% for RYGB), with no severe complications reported, indicating that SADI-S is a safe and effective option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Comparison of SADI-S Versus RYGB in Chinese with Diabetes and BMI< 35kg/m2: a Propensity Score Adjustment Analysis. Sang, Q., Wang, L., Wuyun, Q., et al.[2022]

In a study of 121 super-obese patients (BMI ≥ 50 kg/m²) who underwent the SADI-S procedure, the complication rate was low, with only 3.3% experiencing complications both at 30 days and later, indicating the procedure's safety.

At a median follow-up of 31 months, patients achieved a median excess weight loss of 79.8%, demonstrating the procedure's effectiveness in promoting significant weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. Pennestrì, F., Sessa, L., Prioli, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745527/

Outcomes of Single Anastomosis Duodeno-Ileal Bypass ... Mean percentage excess weight loss (%EWL) was 32% (range: 15% to 53%) at six months, 69.6% (range: 34% to 90%) at one year, and 86.2% (range: 43 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625010700

Efficacy and safety of single-anastomosis duodeno-ileal ... Observational data suggest that SADI-S provides excellent weight loss (with percentage excess weight loss ranging from 67% to 114% at 2 years) ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01070-0/abstract

Efficacy and safety of single-anastomosis duodeno-ileal ... ... sleeve gastrectomy, and presence of type 2 diabetes. The primary endpoint was percentage excess weight loss (%EWL) at 2 years (%EWL=[(weight at ...

4. link.springer.com link.springer.com/article/10.1007/s11695-025-08114-x

Long-Term Outcomes of Single and Dual Anastomosis ... Efficacy. Both procedures effectively promote weight loss, with over 90% of patients meeting the TWL > 20% success criterion at all time points ...

5. asmbs.org asmbs.org/patients/bariatric-surgery-procedures/

Bariatric Surgery Procedures Highly effective for long-term weight loss and remission of type 2 diabetes · Simpler and faster to perform (one intestinal connection) than gastric bypass or ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05064722

Study Details | Duodenal-Ileal Diversion in Obese Patients ... Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve. ClinicalTrials.gov ID NCT05064722.