Endoscopic Band Ligation for Type 2 Diabetes Mellitus (ENDOBAND-DM)
ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEl Katib Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Use of insulin therapy
Previous bariatric or gastrointestinal surgery
Diagnosis of type 1 diabetes mellitus
Known gastrointestinal obstruction, ulcers, or active GI bleeding
Trial design
Treatments tested in this trial
- Endoscopic Band Ligation (ENDOBAND-DM)
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
El Katib Hospital
Lead sponsor
Cairo University
Sponsor institution
Source ClinicalTrials.gov