RECRUITING

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

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Conditions

Diabetes MellitusGastroparesis With Diabetes MellitusGastroparesis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus

Quick Facts

Study Start:2023-01-04
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04696159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients 18 years of age and older
  2. 2. Patients with gastroparesis with an average HbA1c\> 7.5% over the past 3 months
  3. 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. 4. Patients are able to complete all study requirements
  1. 1. Patients \<18 years of age
  2. 2. Patients with gastroparesis with an average HbA1c\< 7.5% over the past 3 months
  3. 3. Patients unable or refuse to complete the study requirements
  4. 4. Patients who are unable or refuse to wear a CGM sensor
  5. 5. Patients with insulin pumps
  6. 6. Patients who already use a CGM

Contacts and Locations

Study Contact

Deanne Nash, RN
CONTACT
216-445-0953
nashd@ccf.org

Principal Investigator

Mathew Allemang, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Matthew Allemang

  • Mathew Allemang, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-04
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-01-04
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus
  • Gastroparesis With Diabetes Mellitus
  • Gastroparesis