Trial Investigating Efficacy of G-POEM

Not Applicable

Recruiting

• Conditions: Gastroparesis With Diabetes Mellitus
• Interventions: Procedure: Sham; Procedure: G-POEM

• Registration Number: NCT05830994
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.

Detailed Description

Study Design The study is a single-centre double-blinded sham-controlled randomized trial. All patients have the same baseline characterization. Patients and researchers will be blinded to allocation in trial. Before randomization patients will have an additional meal test performed addressing metabolic characterization of the incretine hormones at baseline. Patients will afterwards be allocated to either the group receiving G-POEM or to the control group where a sham procedure consisting of a gastroscopy with biopsy during general anaesthesia will be done. The randomization will be carried out per-operatively. A computer-generated bloc randomization with sizes of four will be applied. The study will consist of 5 study visits, with a follow-up of 90 days after procedure. Symptoms and adverse event will be monitored 7, 30, and 90 days after intervention. During the 90-day follow-up all primary and secondary outcome will be reassessed.

G-POEM procedure is carried out in general anaesthesia in the operating theatre at the Department of Surgery, Hvidovre Hospital. Procedures will be performed by experienced surgeons from the Gastro Unit at Hvidovre Hospital,who postoperatively will have no contact with the research team or study participants. Patients will receive the same care during hospitalization.

Patients allocated to sham procedure will have 4 mucosa biopsies from antrum. All biopsies will be handled with formalin and transported to Zealand University Hospital. Here they will be formalin fixed paraffin-embedded and kept in a biobank.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-12
• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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,

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Sham	sham endsocopy with biopsy
G-POEM procedure	G-POEM	Gastric peroral endoscopic myotomy

Primary Outcome Measures

Name	Time	Method
Changes in gastric emptying	90 days after intervention	assessed by technetium scintigraphy

Secondary Outcome Measures

Name	Time	Method
Concentration of C-peptide in pmol/L	90 days after intervention.	Concentration of C-peptide in pmol/L
Changes in continuous glucose	90 days after intervention.	Measure of 10-days interstitial glucose levels with a Dexcom monitor device attached to the abdominal skin
Incidence of Treatment-Emergent Adverse Events rated by the ASGE lexicon for adverse events	7,30 and 90 days	rate and severity of adverse events rated by the ASGE lexicon for adverse events
Changes in postprandial incretinhormones	90 days after intervention.	gastrin, CCK, GIP, GLP-1, GLP-2, glucagon, ghrelin, pancreatic polypeptide (PP)
Changes in gastroparesis cardinal symptom index (GCSI)	7, 30 and 90 days after intervention.	patient-rated gastroparesis cardinal symptom index score for gastroparesis-related symptoms (naseau, vomiting, early satiety, postprandial fulness, upper abdominal pain). Range from 0-none to 5-very servere.
Changes in Plasma glucose	90 days after intervention.	concentration of plasma glucose in mmol/L

Trial Locations

Locations (1)

Melina Svraka Hansen; 🇩🇰 Hvidovre, Region Hovedstaden, Denmark