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Procedure

POP Surgery for Gastroparesis in Diabetes

N/A

Recruiting

Led By Mathew Allemang, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients <18 years of age

Patients with gastroparesis with an average HbA1c< 7.5% over the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new surgery to help manage diabetes in 40 patients who have a stomach condition that has not gotten better with other treatments.

Who is the study for?

This trial is for adults over 18 with diabetes and gastroparesis, confirmed by specific stomach emptying tests. They must have struggled to control their blood sugar levels, with an average HbA1c above 7.5% in the past three months, and be willing to follow all study procedures.

What is being tested?

The trial is testing whether a procedure called per-oral pyloromyotomy (POP), which involves cutting muscles at the stomach's exit to ease food passage, can improve blood sugar control in patients with difficult-to-treat gastroparesis.

What are the potential side effects?

Potential side effects of POP may include discomfort or pain at the procedure site, infection risk, bleeding complications, and possibly changes in digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average blood sugar level has been high over the past 3 months.

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I have been diagnosed with gastroparesis confirmed by a special stomach emptying test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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My average blood sugar level has been below 7.5% over the last 3 months.

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I cannot or will not wear a CGM sensor.

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I cannot or will not follow the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor

Change from Baseline in Hemoglobin A1C levels

Secondary study objectives

Change from Baseline on Diabetes Self-Management Questionnaire

Change from Baseline on Gastroparesis Cardinal Symptom Index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endoscopic Per-Oral Pyloromyotomy (POP)Experimental Treatment1 Intervention

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).

0 / 6Eligibility criteria met