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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Endoscopic Band Ligation (ENDOBAND-DM)
Procedure/SurgeryEndoscopic 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: ENDOBAND-DMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c level from baseline
Mean change in glycosylated hemoglobin (HbA1c) will be measured at 6 months after the endoscopic band ligation procedure, compared to baseline values. This will assess the primary glycemic effect of the intervention.
Time frame
Baseline and 6 months post-interventionSecondary outcomes
1
Change in fasting plasma glucose
Measured in mg/dL to assess improvement in fasting glucose levels after intervention.
Time frame
Baseline and 6 monthsLocations
Sponsors and contacts
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El Katib Hospital
Lead sponsor
Cairo University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: