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Recruiting NCT04696159

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

No phase Interventional Diabetes Mellitus Gastroparesis With Diabetes Mellitus Gastroparesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pyloromyotomy.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Gastroparesis With Diabetes Mellitus, Gastroparesis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This will be a prospective study using HbA1c values and continuous glucose monitoring (CGM) to assess changes in glycemic control in patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis. The study cohort will consist of 40 patients with poor glycemic control who undergo POP. The investigators propose a prospective cohort study using CGM to compare glycemic profiles before and after POP in patients with diabetic gastroparesis. The investigators hypothesize that patients will have improvement in glycemic control and reduced variation in blood glucose levels (% time in hypo/hyperglycemia) after undergoing POP. These results will aid in clinical decision making, and may indicate an earlier need for endoscopic intervention in patients with uncontrolled diabetes and gastroparesis.

Interventions

  • Procedure Pyloromyotomy
    Endoscopic Per-Oral Pyloromyotomy (POP)

Primary outcome measures

  • Change from Baseline in Hemoglobin A1C levels [Time frame: Baseline and 6 Month]
  • Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor [Time frame: Baseline and 6 Month]
Secondary outcome measures (2)
  • Change from Baseline on Diabetes Self-Management Questionnaire [Time frame: Baseline and 6 Month]
  • Change from Baseline on Gastroparesis Cardinal Symptom Index [Time frame: Baseline and 6 Month]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patients with insulin pumps
  • Patients who already use a CGM

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Cleveland Clinic Foundation — Cleveland

Publications

  • Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24. PMID 19249393
  • Rodriguez J, Strong AT, Haskins IN, Landreneau JP, Allemang MT, El-Hayek K, Villamere J, Tu C, Cline MS, Kroh M, Ponsky JL. Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. Ann Surg. 2018 Sep;268(3):421-430. doi: 10.1097/SLA.0000000000002927. PMID 30004920
  • Ramzan Z, Duffy F, Gomez J, Fisher RS, Parkman HP. Continuous glucose monitoring in gastroparesis. Dig Dis Sci. 2011 Sep;56(9):2646-55. doi: 10.1007/s10620-011-1810-z. Epub 2011 Jul 7. PMID 21735078
  • Tanenberg RJ, Pfeifer MA. Continuous glucose monitoring system: a new approach to the diagnosis of diabetic gastroparesis. Diabetes Technol Ther. 2000;2 Suppl 1:S73-80. doi: 10.1089/15209150050214168. No abstract available. PMID 11469637
  • Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015 Mar;9(2):209-14. doi: 10.1177/1932296814559746. Epub 2014 Nov 3. PMID 25370149
  • Role of Continuous Glucose Monitoring in Diabetes Treatment. Arlington (VA): American Diabetes Association; 2018 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK538971/ PMID 30958664

Identifiers

NCT: NCT04696159 · 19-1460

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗