Diabetes MellitusNCT04696159
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
A study testing Pyloromyotomy in people with Diabetes Mellitus and Gastroparesis With Diabetes Mellitus, run by Matthew Allemang at 1 site in United States.
Trial summary
This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Gastroparesis With Diabetes Mellitus, Gastroparesis
- What is being tested?
- Pyloromyotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age and older
- Patients with gastroparesis with an average HbA1c> 7.5% over the past 3 months
- Patient that have a diagnosis of gastroparesis established by documented delayed gastric emptying by either a wireless motility capsule study or a nuclear gastric emptying study, with no evidence of gastric obstruction.
- Patients are able to complete all study requirements
Who cannot join
- Patients <18 years of age
- Patients with gastroparesis with an average HbA1c< 7.5% over the past 3 months
- Patients unable or refuse to complete the study requirements
- Patients who are unable or refuse to wear a CGM sensor
- Patients with insulin pumps
- Patients who already use a CGM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.
Read the detailed description
This will be a prospective study using HbA1c values and continuous glucose monitoring (CGM) to assess changes in glycemic control in patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis. The study cohort will consist of 40 patients with poor glycemic control who undergo POP. The investigators propose a prospective cohort study using CGM to compare glycemic profiles before and after POP in patients with diabetic gastroparesis. The investigators hypothesize that patients will have improvement in glycemic control and reduced variation in blood glucose levels (% time in hypo/hyperglycemia) after undergoing POP. These results will aid in clinical decision making, and may indicate an earlier need for endoscopic intervention in patients with uncontrolled diabetes and gastroparesis.
- Being tested
- Pyloromyotomy
- Medical subject headings
- Diabetes Mellitus, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyloromyotomyProcedure or surgery
Endoscopic Per-Oral Pyloromyotomy (POP)
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Per-Oral Pyloromyotomy (POP) | Experimental | The study cohort will include 40 patients with a HbA1c >7.5% with medically refractory gastroparesis who are scheduled to undergo POP. Each patient will undergo two 10-day periods of CGM at an interval of approximately seven months, one month prior to the procedure and six months after. Symptoms and diabetes management improvement will be measured by the Gastroparesis Cardinal Symptom Index (GCSI) scores and the Diabetes Self-Management Questionnaire (DSMQ). Receives: Procedure: Pyloromyotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1C levels
Glycemic control will be evaluated by measuring change in Hemoglobin A1C (HbA1c) levels. Poor glycemic control defined as an average HbA1c > 7.5%. Change = (Six Month Score - Baseline Score)
Measured: Baseline and 6 Month
Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor
Glycemic control will be evaluated by measuring average glucose levels using Continuous Glucose Monitors (CGM). Normal glucose levels 74-99 mg/dL. Change = (Six Month Score - Baseline Score)
Measured: Baseline and 6 Month
Secondary outcomes (2)
Change from Baseline on Diabetes Self-Management Questionnaire
The Diabetes Self-Management Questionnaire (DSMQ) is a self reported instrument assessing diabetes self-care activities. Possible scores range from 0 (Does not apply) to 3 (Applies to me very much). Change = (Six Month Score - Baseline Score)
Measured: Baseline and 6 Month
Change from Baseline on Gastroparesis Cardinal Symptom Index
The Gastroparesis Cardinal Symptom Index (GCSI) is a validated patient-administered questionnaire that is used to assess gastroparesis symptom severity. Possible scores range from 0 (None) to 5 (Very Severe). Change = (Six Month Score - Baseline Score)
Measured: Baseline and 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start4 Jan 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Allemang
- Sponsor type
- University, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons
- Responsible party
- Sponsor-investigator, Matthew Allemang, The Cleveland Clinic
- Investigators
- Mathew Allemang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696159
- Sponsor's protocol ID
- 19-1460
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24.
PubMed 19249393Rodriguez J, Strong AT, Haskins IN, Landreneau JP, Allemang MT, El-Hayek K, Villamere J, Tu C, Cline MS, Kroh M, Ponsky JL. Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. Ann Surg. 2018 Sep;268(3):421-430. doi: 10.1097/SLA.0000000000002927.
PubMed 30004920Ramzan Z, Duffy F, Gomez J, Fisher RS, Parkman HP. Continuous glucose monitoring in gastroparesis. Dig Dis Sci. 2011 Sep;56(9):2646-55. doi: 10.1007/s10620-011-1810-z. Epub 2011 Jul 7.
PubMed 21735078Tanenberg RJ, Pfeifer MA. Continuous glucose monitoring system: a new approach to the diagnosis of diabetic gastroparesis. Diabetes Technol Ther. 2000;2 Suppl 1:S73-80. doi: 10.1089/15209150050214168. No abstract available.
PubMed 11469637Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015 Mar;9(2):209-14. doi: 10.1177/1932296814559746. Epub 2014 Nov 3.
PubMed 25370149Role of Continuous Glucose Monitoring in Diabetes Treatment. Arlington (VA): American Diabetes Association; 2018 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK538971/
PubMed 30958664
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04696159
- Acronym / sponsor ID
- 19-1460
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Matthew AllemangUniversity, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jan 2021 (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.
This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.
Detailed description
This will be a prospective study using HbA1c values and continuous glucose monitoring (CGM) to assess changes in glycemic control in patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis. The study cohort will consist of 40 patients with poor glycemic control who undergo POP. The investigators propose a prospective cohort study using CGM to compare glycemic profiles before and after POP in patients with diabetic gastroparesis. The investigators hypothesize that patients will have improvement in glycemic control and reduced variation in blood glucose levels (% time in hypo/hyperglycemia) after undergoing POP. These results will aid in clinical decision making, and may indicate an earlier need for endoscopic intervention in patients with uncontrolled diabetes and gastroparesis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Per-Oral Pyloromyotomy (POP) | Experimental | Procedure: PyloromyotomyThe study cohort will include 40 patients with a HbA1c >7.5% with medically refractory gastroparesis who are scheduled to undergo POP. Each patient will undergo two 10-day periods of CGM at an interval of approximately seven months, one month prior to the procedure and six months after. Symptoms and diabetes management improvement will be measured by the Gastroparesis Cardinal Symptom Index (GCSI) scores and the Diabetes Self-Management Questionnaire (DSMQ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of age and older
- Patients with gastroparesis with an average HbA1c> 7.5% over the past 3 months
- Patient that have a diagnosis of gastroparesis established by documented delayed gastric emptying by either a wireless motility capsule study or a nuclear gastric emptying study, with no evidence of gastric obstruction.
- Patients are able to complete all study requirements
Key exclusion criteria (6 listed)
- Patients <18 years of age
- Patients with gastroparesis with an average HbA1c< 7.5% over the past 3 months
- Patients unable or refuse to complete the study requirements
- Patients who are unable or refuse to wear a CGM sensor
- Patients with insulin pumps
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 |
|---|---|---|
| PyloromyotomyEndoscopic Per-Oral Pyloromyotomy (POP) | Procedure or surgery | Endoscopic Per-Oral Pyloromyotomy (POP) |
Primary outcome
Change from Baseline in Hemoglobin A1C levels
Time frame: Baseline and 6 Month
Glycemic control will be evaluated by measuring change in Hemoglobin A1C (HbA1c) levels. Poor glycemic control defined as an average HbA1c > 7.5%. Change = (Six Month Score - Baseline Score)
Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor
Time frame: Baseline and 6 Month
Glycemic control will be evaluated by measuring average glucose levels using Continuous Glucose Monitors (CGM). Normal glucose levels 74-99 mg/dL. Change = (Six Month Score - Baseline Score)
2 secondary outcomes
Change from Baseline on Diabetes Self-Management Questionnaire
Time frame: Baseline and 6 Month
Change from Baseline on Gastroparesis Cardinal Symptom Index
Time frame: Baseline and 6 Month
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 21 Aug 2026.
- Background: PubMed 19249393Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24.
- Background: PubMed 30004920Rodriguez J, Strong AT, Haskins IN, Landreneau JP, Allemang MT, El-Hayek K, Villamere J, Tu C, Cline MS, Kroh M, Ponsky JL. Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. Ann Surg. 2018 Sep;268(3):421-430. doi: 10.1097/SLA.0000000000002927.
- Background: PubMed 21735078Ramzan Z, Duffy F, Gomez J, Fisher RS, Parkman HP. Continuous glucose monitoring in gastroparesis. Dig Dis Sci. 2011 Sep;56(9):2646-55. doi: 10.1007/s10620-011-1810-z. Epub 2011 Jul 7.
- Background: PubMed 11469637Tanenberg RJ, Pfeifer MA. Continuous glucose monitoring system: a new approach to the diagnosis of diabetic gastroparesis. Diabetes Technol Ther. 2000;2 Suppl 1:S73-80. doi: 10.1089/15209150050214168. No abstract available.
- Background: PubMed 25370149Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015 Mar;9(2):209-14. doi: 10.1177/1932296814559746. Epub 2014 Nov 3.
- Background: PubMed 30958664Role of Continuous Glucose Monitoring in Diabetes Treatment. Arlington (VA): American Diabetes Association; 2018 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK538971/
- Clinical Guideline: Management of Gastroparesis \[Internet\]. \[cited 2019 Aug 22\].Link provided by the sponsor.
- 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.
Mathew Allemang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyloromyotomy in people with Diabetes Mellitus and Gastroparesis With Diabetes Mellitus, run by Matthew Allemang at 1 site in United States.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. 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 United States. 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. 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?
Change from Baseline in Hemoglobin A1C levels (time frame: Baseline and 6 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696159, which also lists 6 linked publications.
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 21 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.