Gastroparesis With Diabetes MellitusG-POEMNCT05830994
Trial Investigating Efficacy of G-POEM
A study testing G-POEM in people with Gastroparesis With Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroparesis With Diabetes Mellitus
- What is being tested?
- G-POEM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Apr 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The ability to give signed written informed consent,
- Patients with diabetes and gastroparesis,
- Age >18 years,
- Gastroparesis is diagnosed with technetium-scintigraphy,
- Normal gastroscopy,
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Melina Svraka Hansen
Hvidovre, Capital Region, 2650
Melina S Hansen, +4528304757, melina.svraka.hansen.01@regionh.dk
John PE myotomy, +4540944465, john.gasdal.karstensen@regionh.dk
About this study
Official title: Randomized Sham-controlled Trial Investigating Efficacy of Gastric Peroral Endoscopic Myotomy in Treatment of Diabetic Gastroparesis
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.
Read the 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.
- Conditions
- Gastroparesis With Diabetes Mellitus
- Being tested
- G-POEM, Sham
- Keywords
- gastroparesis, G-POEM, gastric peroral endoscopic myotomy, technetium-scintigraphy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-POEMProcedure or surgery
An Endoscopic submucosal tunnel is formed and extended to the first part of the duodenum, followed by a pyloromyotomy, beginning approximately two centimetres proximal to the pylorus and ending in the first part of duodenum.
ShamProcedure or surgery
Also called Endoscopy with tissue sample
Endoscopy is performed and tissue samples are collected from fundus and antrum as part of the Sham procedure
| Study group | Role | What they receive |
|---|---|---|
| G-POEM procedure | Active comparator | Gastric peroral endoscopic myotomy Receives: Procedure: G-POEM |
| Sham procedure | Placebo comparator | sham endsocopy with biopsy Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gastric emptying
assessed by technetium scintigraphy
Measured: 90 days after intervention
Secondary outcomes (6)
Changes in gastroparesis cardinal symptom index (GCSI)
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.
Measured: 7, 30 and 90 days after intervention.
Changes in Plasma glucose
concentration of plasma glucose in mmol/L
Measured: 90 days after intervention.
Changes in postprandial incretinhormones
gastrin, CCK, GIP, GLP-1, GLP-2, glucagon, ghrelin, pancreatic polypeptide (PP)
Measured: 90 days after intervention.
Concentration of C-peptide in pmol/L
Concentration of C-peptide in pmol/L
Measured: 90 days after intervention.
Changes in continuous glucose
Measure of 10-days interstitial glucose levels with a Dexcom monitor device attached to the abdominal skin
Measured: 90 days after intervention.
Incidence of Treatment-Emergent Adverse Events rated by the ASGE lexicon for adverse events
rate and severity of adverse events rated by the ASGE lexicon for adverse events
Measured: 7,30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start12 Apr 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroparesis With Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Melina Svraka Hansen, Hvidovre University Hospital
- Investigators
- John G Karstensen, MD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830994
- Sponsor's protocol ID
- SJ-981
- Acronym
- G-POEM
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Sham-controlled Trial Investigating Efficacy of Gastric Peroral Endoscopic Myotomy in Treatment of Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT05830994
- Acronym / sponsor ID
- G-POEM / SJ-981
- Conditions
- Gastroparesis With Diabetes Mellitus
- Keywords
- gastroparesis, G-POEM, gastric peroral endoscopic myotomy, technetium-scintigraphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Steno Diabetes Center Copenhagen
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will 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.
| Arm | Type | Receives |
|---|---|---|
| G-POEM procedure | Active comparator | Procedure: G-POEMGastric peroral endoscopic myotomy |
| Sham procedure | Placebo comparator | Procedure: Shamsham endsocopy with biopsy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The ability to give signed written informed consent,
- Patients with diabetes and gastroparesis,
- Age >18 years,
- Gastroparesis is diagnosed with technetium-scintigraphy,
- Normal gastroscopy,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-POEMAn Endoscopic submucosal tunnel is formed and extended to the first part of the duodenum, followed by a pyloromyotomy, beginning approximately two centimetres proximal to the pylorus and ending in the first part of duodenum. | Procedure or surgery | G-POEM procedure |
| ShamAlso: Endoscopy with tissue sampleEndoscopy is performed and tissue samples are collected from fundus and antrum as part of the Sham procedure | Procedure or surgery | Sham procedure |
Primary outcome
Changes in gastric emptying
Time frame: 90 days after intervention
assessed by technetium scintigraphy
6 secondary outcomes
Changes in gastroparesis cardinal symptom index (GCSI)
Time frame: 7, 30 and 90 days after intervention.
Changes in Plasma glucose
Time frame: 90 days after intervention.
Changes in postprandial incretinhormones
Time frame: 90 days after intervention.
Concentration of C-peptide in pmol/L
Time frame: 90 days after intervention.
Changes in continuous glucose
Time frame: 90 days after intervention.
Incidence of Treatment-Emergent Adverse Events rated by the ASGE lexicon for adverse events
Time frame: 7,30 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G Karstensen, MD principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-POEM in people with Gastroparesis With Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melina S Hansen, MD (+4528304757, melina.svraka.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gastric emptying (time frame: 90 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.