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Can a new stomach and gut bypass surgery tackle obesity and diabetes?

NCT ID NCT07765758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests a new laparoscopic procedure called SIBS, which combines sleeve gastrectomy with a side-to-side connection between the duodenum and ileum, without cutting the duodenum. The goal is to see if the surgery is safe and technically feasible in adults with obesity and type 2 diabetes. Participants will be followed for up to 12 months to track weight loss, blood sugar control, and any complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS), a laparoscopic surgical procedure
What this could lead to
If successful, this could offer a safer, simpler bariatric surgery option that improves weight loss and blood sugar control in people with obesity and type 2 diabetes.
What could go wrong
This is an early, single-center study with only 50 participants, so results may not apply broadly. Surgery carries risks like leaks, bleeding, or complications requiring further procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Age 18-65 years. * Body mass index (BMI) ≥35 kg/m², regardless of the presence or severity of obesity-associated medical conditions; or BMI 30.0-34.9 kg/m² with type 2 diabetes mellitus or another clinically significant obesity-associated medical condition and inadequate weight loss or improvement following appropriate nonsurgical management. * Eligible for metabolic and bariatric surgery following multidisciplinary clinical assessment. * Considered suitable for laparoscopic Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) based on preoperative assessment. * For primary procedures, no previous metabolic or bariatric surgical procedure. * For revisional procedures, previous sleeve gastrectomy with a clinical indication for revisional metabolic/bariatric surgery and anatomy considered suitable for SIBS. * Able to understand the investigational nature of the SIBS procedure, its potential risks and benefits, and established alternative bariatric procedures. * Able and willing to provide written informed consent. * Willing and able to comply with the scheduled postoperative clinical, nutritional, laboratory, and study follow-up for at least 12 months. Exclusion Criteria * Age \<18 years or \>65 years. * Pregnancy or breastfeeding. * Planned pregnancy during the 12-month postoperative study period. * Contraindication to general anesthesia or laparoscopic metabolic/bariatric surgery. * Previous gastrointestinal surgery resulting in anatomy that precludes safe performance of the planned SIBS procedure, except previous sleeve gastrectomy in participants undergoing an eligible revisional procedure. * Intraoperative anatomy that prevents safe creation of a tension-free side-to-side duodenoileal anastomosis. * Active inflammatory bowel disease involving the small intestine. * Active gastrointestinal malignancy or other active malignancy for which the proposed operation or follow-up would be inappropriate. * Severe hepatic dysfunction, severe renal dysfunction, or another major systemic illness considered to confer an unacceptable operative or nutritional risk. * Pre-existing severe protein-calorie malnutrition or clinically significant nutritional deficiency that cannot be adequately corrected before surgery. * Active gastrointestinal ulceration or another gastrointestinal condition considered to substantially increase the risk of the planned procedure. * Uncontrolled psychiatric illness or cognitive impairment that precludes valid informed consent or adherence to postoperative care. * Active alcohol or substance use disorder considered incompatible with safe metabolic and bariatric surgery. * Inability or unwillingness to adhere to postoperative dietary recommendations, nutritional supplementation, or scheduled follow-up. * Any medical, surgical, anatomical, or psychosocial condition that, in the judgment of the multidisciplinary bariatric team, makes participation or performance of SIBS inappropriate or unsafe.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Division of Bariatric and Metabolic Surgery, Medical City for Military and Security Services

    Muscat, 111, Oman

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