GastroparesisDIAPOEMNCT06965543
G-POEM for Glycemic Control in Diabetic Gastroparesis
A study testing Immediate G-POEM and Delayed G-POEM in people with Gastroparesis, run by French Society of Digestive Endoscopy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Immediate G-POEM and Delayed G-POEM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Continuous glucose monitoring (CGM) in use or willingness to use during study
- Time in range (70-180 mg/dL) <70%
Who cannot join
- 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;
- Are pregnant or breastfeeding during the study period;
- Are under legal guardianship;
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- Have contraindications to the POEM procedure, including contraindications to anesthesia and/or active anticoagulation that cannot be paused;
- Have severe chronic constipation, defined by a Cleveland score >15 (Agachan et al., Dis Colon Rectum, 1996);
- Have a history of esophagogastric surgery (excluding anti-reflux surgery), including esophagogastric resection or any type of bariatric surgery;
- Have chronic intestinal pseudo-obstruction;
- Have a clinical suspicion of chronic mesenteric ischemia, indicated by severe malnutrition, postprandial pain, and signs of digestive atherosclerosis;
- Refuse to share CGM data via the Libre Link platform;
- Plan or undergo changes in antidiabetic therapy or insulin delivery systems during the study period;
- Are being treated with any gastric-emptying delaying agents, including GLP-1 receptor agonists;
- Are undergoing treatment with ascorbic acid during the study;
- Have not previously attempted therapy with at least one prokinetic drug;
- Are actively treated with opioids;
- Have had prior pyloromyotomy or pyloroplasty;
- Have known eosinophilic gastroenteritis;
- Have an organic obstruction of the pylorus or intestinal tract (e.g., fibrotic stenosis);
- Have a severe coagulopathy;
- Have esophageal or gastric varices and/or portal hypertension gastropathy;
- Have decompensated liver cirrhosis (Child B or Child C);
- Have an active gastroduodenal ulcer;
- Have active cancer or precancerous conditions of the stomach or duodenum (dysplasia, gastric cancer, GIST).
- Have a known medical condition that, in the investigator's opinion, could interfere with the study protocol;
- Have experienced diabetic ketoacidosis requiring hospitalization within six months prior to enrollment;
- Have had a severe hypoglycemic episode requiring hospitalization within six months prior to enrollment.
About this study
Official title: Randomized Controlled Clinical Trial Evaluating the Effect of Endoscopic Pyloromyotomy Via Gastric POEM on Glycemic Control in Patients With Diabetes and Gastroparesis
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.
Read the detailed description
Gastroparesis is a condition characterized by delayed gastric emptying, resulting in various digestive symptoms. Diabetes is the leading global cause of gastroparesis. This complication affects approximately 30-50% of individuals with diabetes, typically appearing after many years of disease progression and frequently in the presence of other vascular complications. It is associated with autonomic neuropathy and hyperglycemia.
The bidirectional relationship between gastric emptying and blood glucose levels contributes to the complexity of diabetes management, increasing the risk of both postprandial hypoglycemia and delayed hyperglycemia. Existing treatments, including prokinetic and antiemetic medications, are often poorly tolerated and of limited efficacy.
G-POEM (Gastric Per Oral Endoscopic Myotomy) is an endoscopic technique designed to treat refractory gastroparesis by targeting pyloric muscle hypertonicity. This procedure has demonstrated favorable outcomes in approximately two-thirds of cases and presents a favorable safety profile. The diabetic population appears to benefit most from this intervention, with over 80% reporting symptom improvement. To date, no study has evaluated the impact of G-POEM on glycemic parameters in patients with diabetic gastroparesis. This clinical trial aims to address this knowledge gap.
- Conditions
- Gastroparesis
- Being tested
- Immediate G-POEM, Delayed G-POEM
- Keywords
- G-POEM (Gastric Per Oral Endoscopic Myotomy), Gastroparesis, diabetic gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate G-POEMProcedure or surgery
Gastric POEM (G-POEM) performed under general anesthesia. A submucosal tunnel will be created along the greater curvature of the stomach to access the pyloric muscle under endoscopic vision. The pylorus will be incised at two locations with a dual myotomy between the 5 and 8 o'clock positions on the clock face
Delayed G-POEMProcedure or surgery
Participants will receive standard medical treatment, including prokinetic agents, antiemetics (ondansetron 8 mg twice daily), nutritional support, and dietary counseling. Laxative treatments will be prescribed as needed. After three months, participants will undergo G-POEM as described above
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Immediate G-POEM | Experimental | Not described Receives: Procedure: Immediate G-POEM |
| Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months | Active comparator | Not described Receives: Procedure: Delayed G-POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in target glycemic range >10%
Proportion of time in the glycemic range 70-180 mg/dL calculated from CGM data over 14 days preceding the 3-month time point
Measured: 3 months after randomization
Secondary outcomes (14)
HbA1c Level
Glycated hemoglobin (HbA1c) level measured in blood samples
Measured: 15 days, 3 months, and 6 months after randomization
Time in Hypoglycemia (<70 mg/dL)
Percentage of time spent with glucose values below 70 mg/dL, based on continuous glucose monitoring (CGM) data.
Measured: 15 days, 3 months, and 6 months after randomization
Time in Hypoglycemia (<54 mg/dL)
Percentage of time spent with glucose values below 54 mg/dL, based on continuous glucose monitoring (CGM) data.
Measured: 15 days, 3 months, and 6 months after randomization
Time in Hyperglycemia (>180 mg/dL)
Percentage of time spent with glucose values above 180 mg/dL, based on continuous glucose monitoring (CGM) data.
Measured: 15 days, 3 months, and 6 months after randomization
Time in Hyperglycemia (>250 mg/dL)
Percentage of time spent with glucose values above 250 mg/dL, based on continuous glucose monitoring (CGM) data.
Measured: 15 days, 3 months, and 6 months after randomization
Mean Glucose Level (mg/dL)
Mean glucose level recorded by CGM over the specified time period.
Measured: 15 days, 3 months, and 6 months after randomization
Coefficient of Variation (CV) of Glucose (%)
Coefficient of variation of glucose levels measured by CGM.
Measured: 15 days, 3 months, and 6 months after randomization
Gastric Emptying Assessment
Evaluation of gastric motility via scintigraphy to measure gastric retention at 1h, 2h, and 4h post-standardized meal, performed at each follow-up time point (15 days, 3 months, and 6 months).
Measured: 15 days, 3 months, and 6 months
Fundic Accommodation Ratio
Calculation of fundic accommodation using the ratio of T0 proximal activity to T0 total activity as per Orthey et al.
Measured: 15 days, 3 months, and 6 months
Gastroparesis Symptom Severity (GCSI Score)
Gastroparesis symptoms assessed with the Gastroparesis Cardinal Symptom Index (GCSI), a validated questionnaire with a scale ranging from 0 to 5, where higher scores indicate more severe symptoms.
Measured: 15 days, 3 months, and 6 months
Severity of Upper GI Symptoms (PAGI-SYM Score)
Patient-reported outcome measuring severity of upper GI symptoms using the PAGI-SYM questionnaire, a validated questionnaire with a scale from 0 to 5, where higher scores represent worse symptom severity.
Measured: 15 days, 3 months, and 6 months
Gastrointestinal Quality of Life (GIQLI Score)
Quality of life related to gastrointestinal symptoms using the validated French version of the GIQLI scale.The total score ranges from 0 to 144, with higher scores indicating better quality of life.
Measured: 15 days, 3 months, and 6 months
Postprandial abdominal pain (VAS)
Intensity of postprandial abdominal pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 15 days, 3 months, and 6 months
Safety and Adverse Events
Number of participants experiencing serious or unexpected adverse events throughout the follow-up.
Measured: From inclusion to the end of the 6-month follow-up, over a total study duration of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society of Digestive Endoscopy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine DEBOURDEAU, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965543
- Sponsor's protocol ID
- SFED-166
- Acronym
- DIAPOEM
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial Evaluating the Effect of Endoscopic Pyloromyotomy Via Gastric POEM on Glycemic Control in Patients With Diabetes and Gastroparesis
- ClinicalTrials.gov ID
- NCT06965543
- Acronym / sponsor ID
- DIAPOEM / SFED-166
- Conditions
- Gastroparesis
- Keywords
- G-POEM (Gastric Per Oral Endoscopic Myotomy), Gastroparesis, diabetic gastroparesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- French Society of Digestive EndoscopyUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 11 May 2025 (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.
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.
Detailed description
Gastroparesis is a condition characterized by delayed gastric emptying, resulting in various digestive symptoms. Diabetes is the leading global cause of gastroparesis. This complication affects approximately 30-50% of individuals with diabetes, typically appearing after many years of disease progression and frequently in the presence of other vascular complications. It is associated with autonomic neuropathy and hyperglycemia.
The bidirectional relationship between gastric emptying and blood glucose levels contributes to the complexity of diabetes management, increasing the risk of both postprandial hypoglycemia and delayed hyperglycemia. Existing treatments, including prokinetic and antiemetic medications, are often poorly tolerated and of limited efficacy.
G-POEM (Gastric Per Oral Endoscopic Myotomy) is an endoscopic technique designed to treat refractory gastroparesis by targeting pyloric muscle hypertonicity. This procedure has demonstrated favorable outcomes in approximately two-thirds of cases and presents a favorable safety profile. The diabetic population appears to benefit most from this intervention, with over 80% reporting symptom improvement. To date, no study has evaluated the impact of G-POEM on glycemic parameters in patients with diabetic gastroparesis. This clinical trial aims to address this knowledge gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Immediate G-POEM | Experimental | Procedure: Immediate G-POEM |
| Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months | Active comparator | Procedure: Delayed G-POEM |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Continuous glucose monitoring (CGM) in use or willingness to use during study
Key exclusion criteria (28 listed)
- 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;
- Are pregnant or breastfeeding during the study period;
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 |
|---|---|---|
| Immediate G-POEMGastric POEM (G-POEM) performed under general anesthesia. A submucosal tunnel will be created along the greater curvature of the stomach to access the pyloric muscle under endoscopic vision. The pylorus will be incised at two locations with a dual myotomy between the 5 and 8 o'clock positions on the clock face | Procedure or surgery | Experimental Group: Immediate G-POEM |
| Delayed G-POEMParticipants will receive standard medical treatment, including prokinetic agents, antiemetics (ondansetron 8 mg twice daily), nutritional support, and dietary counseling. Laxative treatments will be prescribed as needed. After three months, participants will undergo G-POEM as described above | Procedure or surgery | Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months |
Primary outcome
Percentage of time spent in target glycemic range >10%
Time frame: 3 months after randomization
Proportion of time in the glycemic range 70-180 mg/dL calculated from CGM data over 14 days preceding the 3-month time point
14 secondary outcomes
HbA1c Level
Time frame: 15 days, 3 months, and 6 months after randomization
Time in Hypoglycemia (<70 mg/dL)
Time frame: 15 days, 3 months, and 6 months after randomization
Time in Hypoglycemia (<54 mg/dL)
Time frame: 15 days, 3 months, and 6 months after randomization
Time in Hyperglycemia (>180 mg/dL)
Time frame: 15 days, 3 months, and 6 months after randomization
Time in Hyperglycemia (>250 mg/dL)
Time frame: 15 days, 3 months, and 6 months after randomization
Mean Glucose Level (mg/dL)
Time frame: 15 days, 3 months, and 6 months after randomization
Coefficient of Variation (CV) of Glucose (%)
Time frame: 15 days, 3 months, and 6 months after randomization
Gastric Emptying Assessment
Time frame: 15 days, 3 months, and 6 months
Fundic Accommodation Ratio
Time frame: 15 days, 3 months, and 6 months
Gastroparesis Symptom Severity (GCSI Score)
Time frame: 15 days, 3 months, and 6 months
Severity of Upper GI Symptoms (PAGI-SYM Score)
Time frame: 15 days, 3 months, and 6 months
Gastrointestinal Quality of Life (GIQLI Score)
Time frame: 15 days, 3 months, and 6 months
Postprandial abdominal pain (VAS)
Time frame: 15 days, 3 months, and 6 months
Safety and Adverse Events
Time frame: From inclusion to the end of the 6-month follow-up, over a total study duration of 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate G-POEM and Delayed G-POEM in people with Gastroparesis, run by French Society of Digestive Endoscopy.
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 6 inclusion and 28 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: opening soon, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent in target glycemic range >10% (time frame: 3 months after randomization). 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 11 May 2025.