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

ConditionsDiabetes MellitusGastroparesis With Diabetes MellitusGastroparesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Allemang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Pyloromyotomy

    Procedure/Surgery

    Endoscopic Per-Oral Pyloromyotomy (POP)

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Endoscopic Per-Oral Pyloromyotomy (POP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline and 6 Month
2

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)

Time frame
Baseline and 6 Month

Secondary outcomes

1

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)

Time frame
Baseline and 6 Month
2

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)

Time frame
Baseline and 6 Month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matthew Allemang

Lead sponsor

The Cleveland Clinic

Sponsor institution

Society of American Gastrointestinal and Endoscopic Surgeons

Collaborator

Source ClinicalTrials.gov
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