Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Matthew Allemang
Study ID
NCT04696159
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes Mellitus
  • Gastroparesis
  • Gastroparesis With Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pyloromyotomy — PROCEDURE
    Endoscopic Per-Oral Pyloromyotomy (POP)

Study Details

This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.

Key Dates

Start date
Jan 4, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Endoscopic Per-Oral Pyloromyotomy (POP)
    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).

Primary Outcome Measure

Change from Baseline in Hemoglobin A1C levels [ Time Frame: Baseline and 6 Month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Mathew Allemang, MD
[email protected]
216 491-7861

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By research site
Cleveland Clinic Foundation· Cleveland, OH

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