Can a stomach muscle cut tame diabetes blood sugar?

NCT ID NCT04696159

Ongoing Disease control Sponsor: Matthew Allemang Source: ClinicalTrials.gov ↗

Running, but no longer taking on new participants.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether a procedure called per-oral pyloromyotomy (POP), which relaxes the stomach's outlet muscle, can improve blood sugar control in people with diabetes and gastroparesis (delayed stomach emptying). About 40 adults with poorly controlled diabetes (HbA1c above 7.5%) will undergo the procedure and be monitored for six months. The study measures changes in HbA1c and continuous glucose monitor readings to see if the procedure helps.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Endoscopic Per-Oral Pyloromyotomy (POP), a procedure to widen the stomach outlet
What this could lead to: If successful, this procedure could offer a new way to improve blood sugar control in people with diabetes and gastroparesis, potentially reducing complications.
What could go wrong: This is a small, early-stage study. The procedure may not improve blood sugar for everyone, and it carries risks typical of any endoscopic surgery, such as bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients 18 years of age and older 2. Patients with gastroparesis with an average HbA1c\> 7.5% over the past 3 months 3. 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. 4. Patients are able to complete all study requirements Exclusion Criteria: 1. Patients \<18 years of age 2. Patients with gastroparesis with an average HbA1c\< 7.5% over the past 3 months 3. Patients unable or refuse to complete the study requirements 4. Patients who are unable or refuse to wear a CGM sensor 5. Patients with insulin pumps 6. Patients who already use a CGM

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gastroparesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DIABETES MELLITUS GASTROPARESIS GASTROPARESIS WITH DIABETES MELLITUS

Contacts and locations

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

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