Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Gut reroute surgery shows promise for diabetes control

NCT ID NCT03130244

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests a procedure that reroutes part of the small intestine to help control type 2 diabetes and weight. About 15 adults with diabetes and obesity will be followed for a year to see if their blood sugar and weight improve. The goal is to reduce the need for diabetes medications, but ongoing management may still be needed.

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

15 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Body mass index (BMI) 30 to 50. * Subject Type 2 Diabetes Criteria: 1. T2DM diagnosis ≥6 months but \< 10 years 2. On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose) 3. Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., \<0.3% reduction) 4. Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit. * If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled. * Able to understand and sign informed consent document * Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions Exclusion Criteria: * Known or suspected allergy to nickel or titanium or Nitinol * Type 1 Diabetes * Use of injectable insulin * Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) * Probable insulin production failure, defined as fasting serum C Peptide \<1 ng/mL (0.3 nmol/l) * Any documented conditions for which endoscopy/colonoscopy would be contraindicated. * Contraindication to general anesthesia * Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation. * Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon. * Previous technically difficult or failed colonoscopy or endoscopy * If on metformin, history of polycystic ovarian syndrome (PCOS) * Unable or unwilling to perform home blood glucose monitoring * History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease) * Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin * Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves. * Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Obesity are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Contacts and locations

Locations

  • Aleman Hospital

    Buenos Aires, C1118AAT, Argentina

More trials for these conditions

Other studies related to the condition(s) this trial covers.