Evaluation of endoscopic band ligation for treatment of type 2 diabetes: a Single-Center interventional study

NCT ID NCT07117721

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

This is a pilot clinical study evaluating the safety and feasibility of Endoscopic Band Ligation (ENDOBAND-DM) applied to the second through fourth parts of the duodenum - from just distal to the ampulla of Vater to the ligament of Treitz - in patients with type 2 diabetes mellitus (T2DM). The goal is to induce mucosal remodeling in this duodenal segment, potentially enhancing gut hormone signaling and improving glycemic control. Participants will be monitored for changes in HbA1c, fasting glucose, and insulin sensitivity over 6-12 months.

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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 10 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

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

18 to 70 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 between 18 and 70 years * Confirmed diagnosis of type 2 diabetes mellitus * HbA1c between 7.5% and 10.5% at screening * Body Mass Index (BMI) between 27 and 40 kg/m² * Stable use of oral antidiabetic medications for ≥3 months prior to enrollment * Willingness to undergo endoscopic procedure and attend all follow-up visits * Signed informed consen Exclusion Criteria: * Use of insulin therapy * Previous bariatric or gastrointestinal surgery * Diagnosis of type 1 diabetes mellitus * Known gastrointestinal obstruction, ulcers, or active GI bleeding * History of pancreatitis, biliary disease, or abnormal anatomy in duodenum * Pregnancy or breastfeeding * Severe comorbidities (e.g., uncontrolled cardiovascular disease, advanced kidney or liver disease) * Use of GLP-1 receptor agonists within 3 months prior to enrollment * Inability or unwillingness to comply with the study protocol

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Conditions

The condition(s) this trial relates to.

Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

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

How to take part

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