Gut reroute surgery shows promise for diabetes control
NCT ID NCT03130244
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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15 people
The number who actually took part.
- Started
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Sep 2019
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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)
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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.
Contacts and locations
Locations
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Aleman Hospital
Buenos Aires, C1118AAT, Argentina
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