Endoscopic Band Ligation for Type 2 Diabetes Mellitus (ENDOBAND-DM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Band Ligation (ENDOBAND-DM).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Endoscopic Band Ligation for Treatment of Type 2 Diabetes: A Single-Center Interventional Study
Overview
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.
Detailed 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.
Interventions
- Procedure Endoscopic Band Ligation (ENDOBAND-DM)
Endoscopic band ligation of the second through fourth parts of the duodenum, from just distal to the ampulla of Vater to the ligament of Treitz. The aim is to induce localized mucosal remodeling that may enhance enteroendocrine signaling (GLP-1, GIP) and improve glycemic control in patients with type 2 diabetes mellitus.
Primary outcome measures
- Change in HbA1c level from baseline [Time frame: Baseline and 6 months post-intervention]
Secondary outcome measures (1)
- Change in fasting plasma glucose [Time frame: Baseline and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Abeid M, Zaitoun N. Endoscopic Band Ligation for Weight Loss: A Clinical Trial. Obes Surg. 2025 Jan;35(1):280-284. doi: 10.1007/s11695-024-07609-3. Epub 2024 Dec 20. PMID 39707144
Identifiers
NCT: NCT07117721 · M.Abeid-ENDOBAND-DM-2025