Diabetes Mellitus, Gastroparesis With Diabetes Mellitus, Gastroparesis
Conditions
Brief summary
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
PROCEDUREPyloromyotomy
Endoscopic Per-Oral Pyloromyotomy (POP)
Sponsors
Society of American Gastrointestinal and Endoscopic Surgeons
Matthew Allemang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor | Baseline and 6 Month | 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) |
| Change from Baseline in Hemoglobin A1C levels | Baseline and 6 Month | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on Diabetes Self-Management Questionnaire | Baseline and 6 Month | 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) |
| Change from Baseline on Gastroparesis Cardinal Symptom Index | Baseline and 6 Month | 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) |
Countries
United States
Contacts
Primary ContactDeanne Nash, RN
Outcome results
None listed