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

El Katib Hospital

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Procedure: Endoscopic Band Ligation (ENDOBAND-DM)

Study type: Interventional

Funder types: Other

Identifiers

NCT07117721

M.Abeid-ENDOBAND-DM-2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ENDOBAND-DM

Experimental group

Description:

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.

Treatment:

Procedure: Endoscopic Band Ligation (ENDOBAND-DM)