| Registry | NCT07526103 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 40 (Estimated) |
| Sponsor | Queen's University (Other) |
| Conditions | Hypoglycaemia, Diabete Mellitus, Colonoscopy (Ambulatory Patients) |
| Interventions | timing of cleansing and procedure (Other) |
| Dates | start 2026-06-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-04-13, last updated 2026-04-24 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Hypoglycaemia All trials for Diabete Mellitus All trials of timing of cleansing and procedure
Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied.
Studies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation.
This study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group (Standard Preparation) | Active comparator | Other: timing of cleansing and procedure | Participants will follow a clear-liquid diet after breakfast on the day before colonoscopy. They will ingest 2L of PEG at 7:00 PM the evening before the procedure and the remaining 2L four hours prior to colonoscopy. |
| Diabetes-Specific Protocol Group | Experimental | Other: timing of cleansing and procedure | Participants will follow a four-day, low-fiber carbohydrate diet. They will be allowed to consume dinner up until 7:00 PM the night before the colonoscopy. On the day of the procedure, they will ingest 2L of PEG between 5:00 AM and 6:00 AM and the remaining 2L between 8:00 AM and 9:00 AM. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: 1. Patients Age over the age of 18 2. Able to read and understand the English language 3. Confirmed diagnosis of diabetes (Type 1 or Type 2) Exclusion Criteria: 1. Patients without diabetes 2. Patients with prior hospital admission due to hypoglycemic events 3. Patients who have inflammatory bowel disease 4. Patients with ileus or bowel obstruction 5. Patients with history of colorectal resection 6. Patients receiving combined upper and lower endoscopies 7. Patients with ascites 8. Patients with previously documented severe renal impairment 9. Unable to provide consent 10. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing) 11. Patients who have had a recent myocardial infarction(<6months) 12. Allergy to product ingredients
| Facility | City | Country | Status |
|---|---|---|---|
| Kingston Health Sciences Centre | Kingston, Ontario | Canada |