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Could rerouting the gut and cutting nerves free people from diabetes drugs?

NCT ID NCT02949687

Disease control Sponsor: Universidade Positivo Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial investigates a surgical procedure for people with type 2 diabetes and mild obesity (grade 1). The surgery combines three steps: rerouting part of the small intestine, reducing the stomach size, and cutting certain abdominal nerves. The goal is to see if this approach can bring blood sugar levels to normal without the need for diabetes medications. The study follows participants for 24 months to measure success.

What this could mean

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

Active substance
laparoscopic ileal interposition with sleeve and sympathectomy
What this could lead to
If successful, this surgery could allow some people with type 2 diabetes and mild obesity to stop taking diabetes medications while maintaining normal blood sugar levels.
What could go wrong
This is a small, early-stage surgical trial with no control group, so results may not apply widely. Surgery carries risks like infection, bleeding, and long-term digestive changes.

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

23 people

The number who actually took part.

Started

Sep 2016

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

20 to 60 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: * Documented diagnosis of type 2 diabetes mellitus * Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors * Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks * HbA1c\> 8.0% * Age\> 20 years and \<60 years * Body mass index (BMI) of 30 35 kg / m² * Agree to sign the consent form Exclusion Criteria: * Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation \<0.5 ng / ml) * Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors * Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months) * Malignant neoplasm * Portal hypertension * Inability to cooperate with segment * Low capacity of understanding surgery * Unrealistic expectations of the outcome * Cognitive impairment * Current pregnancy * Moderate or severe mood disorder; severe anxiety; eating disorders (based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria) * Chemical dependency or alcoholism (based on DSM-V criteria).

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus Obesity

More trials for these conditions

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