G-POEM for Glycemic Control in Diabetic Gastroparesis
ConditionGastroparesis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFrench Society of Digestive Endoscopy
About this trial
Gastroparesis, commonly caused by diabetes, affects 30-50% of diabetic individuals and complicates glycemic control due to its bidirectional relationship with blood glucose levels. Current treatments are often ineffective. G-POEM, a minimally invasive endoscopic technique, has demonstrated promising results in improving digestive symptoms, particularly in diabetic patients, with over 80% success. However, its impact on glycemic control has not yet been investigated, highlighting the need for further research.
Eligibility criteria
Qualifiers
Aged 18 to 90 years;
Diagnosed with diabetes for at least 5 years and be treated with optimized insulin therapy;
Severe gastroparesis with gastric retention >20% at 4h (confirmed by scintigraphy);
Failure of conventional gastroparesis treatment;
Disqualifiers
Are treated with an automated insulin therapy system (closed-loop);
Have previously undergone gastric neurostimulation therapy with Enterra (Medtronic ©);
Have been treated with erythromycin in the past three months;
Do not provide informed consent;
Trial design
Treatments tested in this trial
- Immediate G-POEM
- Delayed G-POEM
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov