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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696159
• Other study ID #: 19-1460
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: Deanne Nash, RN
• Phone: 216-445-0953
• Email: nashd[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients 18 years of age and older

2. Patients with gastroparesis with an average HbA1c> 7.5% over the past 3 months

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. Patients are able to complete all study requirements

Exclusion Criteria:

1. Patients <18 years of age

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

3. Patients unable or refuse to complete the study requirements

4. Patients who are unable or refuse to wear a CGM sensor

5. Patients with insulin pumps

6. Patients who already use a CGM

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis
• Gastroparesis With Diabetes Mellitus

Intervention

Procedure:
• Pyloromyotomy
Endoscopic Per-Oral Pyloromyotomy (POP)

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Matthew Allemang	Society of American Gastrointestinal and Endoscopic Surgeons

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and 6 Month
Primary	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)	Baseline and 6 Month
Secondary	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)	Baseline and 6 Month
Secondary	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)	Baseline and 6 Month

External Links

•   Clinical Guideline: Management of Gastroparesis [Internet]. [cited 2019 Aug 22].