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Endoscopic Band Ligation for Type 2 Diabetes Mellitus (ENDOBAND-DM)

Not Yet RecruitingNA

Sponsor: El Katib Hospital

Conditions: Type 2 Diabetes Mellitus (T2DM)

Interventions: Endoscopic Band Ligation (ENDOBAND-DM)

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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