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

Recruiting at 1 trial location

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

18 Participants Needed

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?

Research shows that similar procedures, like sleeve gastrectomy with ileal interposition, have been effective in improving type 2 diabetes in both obese and non-obese patients. These studies suggest that combining these surgical techniques can help control diabetes and aid in weight loss. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

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. ^{1 2 3 5 9}

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Improvement of islet β-cell function after sleeve gastrectomy with ileal interposition duodenojejunal bypass in non-obese type 2 diabetes mellitus]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of type 2 diabetes in patients with BMI below 35: mid-term outcomes of the laparoscopic ileal interposition associated with a sleeve gastrectomy in 202 consecutive cases. [2021]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Short-term and mid-term control of type 2 diabetes mellitus by laparoscopic sleeve gastrectomy with ileal interposition. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Ileal interposition coupled with duodenal diverted sleeve gastrectomy versus standard medical treatment in type 2 diabetes mellitus obese patients: long-term results of a case-control study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Technical feasibility and safety profile of laparoscopic diverted sleeve gastrectomy with ileal transposition (DSIT). [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy/One Anastomosis Duodenal Switch (SADI-S/OADS) IFSO Position Statement-Update 2020. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Duodenal diverted sleeve gastrectomy with ileal interposition does not cause biliary salt malabsorption. [2015]