Evaluation of Endoscopic Band Ligation for Treatment of Type 2 Diabetes: A Single-Center Interventional Study
| Registry | NCT07117721, acronym ENDOBAND-DM |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 10 (Estimated) |
| Sponsor | El Katib Hospital (Other) |
| Conditions | Type 2 Diabetes Mellitus (T2DM) |
| Interventions | Endoscopic Band Ligation (ENDOBAND-DM) (Procedure) |
| Dates | start 2027-01-01 (estimated), primary completion 2029-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2025-08-12, last updated 2026-09-10 |
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All trials for Type 2 Diabetes Mellitus (T2DM) All trials of 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.
The duodenum is a key site of nutrient sensing and hormonal regulation, and duodenal dysfunction contributes to the pathophysiology of type 2 diabetes mellitus (T2DM).
This single-center prospective pilot study investigates Endoscopic Band Ligation (ENDOBAND-DM) targeting the second through fourth parts of the duodenum, beginning just distal to the ampulla of Vater and extending to the ligament of Treitz.
The endoscopic application of elastic bands is designed to induce localized mucosal changes in the duodenum, potentially modulating enteroendocrine responses such as GLP-1 and GIP secretion and improving insulin sensitivity.
Adult participants with suboptimally controlled T2DM (HbA1c 7.5-10.5%) who are not on insulin therapy will undergo a single EBL session. Follow-up will occur at 1, 3, 6, and 12 months post-intervention.
Primary outcome: Change in HbA1c at 6 months. Secondary outcomes include changes in fasting glucose, insulin resistance indices (e.g., HOMA-IR), gut hormones, weight, and adverse events.
This study introduces a novel endoscopic approach aimed at duodenal mucosal modulation for metabolic benefit in type 2 diabetes.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ENDOBAND-DM | Experimental | Procedure: Endoscopic Band Ligation (ENDOBAND-DM) | Participants in this arm will undergo endoscopic band ligation (ENDOBAND-DM) targeting the second through fourth parts of the duodenum, from just distal to the ampulla of Vater to the ligament of Treitz. The procedure is designed to induce localized mucosal changes that may enhance enteroendocrine signaling (e.g., GLP-1, GIP) and improve glycemic control in patients with type 2 diabetes mellitus. |
Sex: All, ages: 18 Years to 70 Years
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