Investigating G-POEM for treating diabetic gastroparesis
Randomized Sham-controlled Trial Investigating Efficacy of Gastric Peroral Endoscopic Myotomy in Treatment of Diabetic Gastroparesis
NA · Hvidovre University Hospital · NCT05830994
This study is testing a new endoscopic procedure called G-POEM to see if it can help people with diabetic gastroparesis feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hvidovre University Hospital (other) |
| Locations | 1 site (Hvidovre, Region Hovedstaden) |
| Trial ID | NCT05830994 on ClinicalTrials.gov |
What this trial studies
This randomized sham-controlled trial aims to evaluate the efficacy and safety of G-POEM, a novel endoscopic procedure, in patients suffering from diabetic gastroparesis. The study will involve a single-center, double-blinded design where participants will be randomly assigned to receive either the G-POEM intervention or a sham procedure. Prior to randomization, patients will undergo a meal test to assess their metabolic response and incretine hormone levels. The trial will include five study visits and a follow-up period of 90 days to monitor symptoms and any adverse events.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of diabetic gastroparesis confirmed by technetium-scintigraphy.
Not a fit: Patients with ongoing cancer treatment, recent gastrointestinal surgery, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients with diabetic gastroparesis.
How similar studies have performed: While the G-POEM approach is relatively novel, similar endoscopic interventions have shown promise in treating other gastrointestinal motility disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The ability to give signed written informed consent, * Patients with diabetes and gastroparesis, * Age \>18 years, * Gastroparesis is diagnosed with technetium-scintigraphy, * Normal gastroscopy, Exclusion Criteria: * Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator, * Recent gastrointestinal surgery, * Active duodenal/gastric ulcer disease, * Diseases in the ventricle or previously complicated upper abdominal surgery, * Previous bariatric surgery, * Pregnancy or breastfeeding, * Parkinson disease, * Persons who, in the judgement of the investigator, may be unable to follow the protocol, Use of metoclopramide, domperidone, prucalopride, ghrelin, macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin) during study period. * drugs with an anti-cholinergic mechanism, * Use of motility slowing agents: anticholinergic agents, calcium channel blockers, TCA, GLP-1 analogs, Lithium, diphenhydramin, glucagon, dopamine agonists, progesterone, L-dopa, calcitonine, octreotide, interferon alfa, sucralsulfate, * botulinum toxin injections (eg, Botox®) by pyloric injection less than 4 months prior to procedure
Where this trial is running
Hvidovre, Region Hovedstaden
- Melina Svraka Hansen — Hvidovre, Region Hovedstaden, Denmark (RECRUITING)
Study contacts
- Principal investigator: John G Karstensen, MD — Copenhagen University Hospital, Hvidovre
- Study coordinator: Melina S Hansen, MD
- Email: melina.svraka.hansen.01@regionh.dk
- Phone: +4528304757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroparesis With Diabetes Mellitus, gastroparesis, G-POEM, gastric peroral endoscopic myotomy, technetium-scintigraphy