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| ID | Type | Description | Link |
|---|---|---|---|
| 3698 | Other Grant/Funding Number | PSI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (Standard Preparation) | Active Comparator | 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. |
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| Diabetes-Specific Protocol Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| timing of cleansing and procedure | Other | we are altering the timing of colonoscopy and cleansing for colonoscopy for patients with diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bowel Preparation | Primary outcome is the proportion of patients achieving an adequate bowel preparation, defined as a Boston bowel preparation scale (BBPS) score of 6 or greater, with no section scoring below 2 . The scale ranges from 0-9, with 9 being the best possible score. | During colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Monitoring | Evaluating the incidence of hypoglycemic events (blood glucose <3.9 mmol/L) from the initiation of bowel preparation until discharge from colonoscopy suite. | Pericolonoscopy period |
| Patient Rating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Hookey, MD | Contact | 613 544 3400 | 2292 | lawrence.hookey@kingstonhsc.ca |
| Amani Khan, MD | Contact | 647 628 9700 | amani.khan@kingstonhsc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37089939 | Background | Tong Y, Huang JQ, Chen Y, Tu M, Wang W. Impact of glucagon-like peptide 1 receptor agonist liraglutide and dipeptidyl peptidase-4 inhibitor sitagliptin on bowel cleaning and gastrointestinal symptoms in type 2 diabetes. Front Pharmacol. 2023 Apr 6;14:1176206. doi: 10.3389/fphar.2023.1176206. eCollection 2023. | |
| 27490086 | Background |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Diabetes-Specific Protocol Group: 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. Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device.
Control Group (Standard Preparation): 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.Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device.
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Patient-reported ratings of convenience, tolerability and adverse events associated with the preparation protocol.
| Pericolonoscopy period |
| Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4. |
| 31567921 | Background | Seo M, Gweon TG, Huh CW, Ji JS, Choi H. Comparison of Bowel Cleansing Efficacy, Safety, Bowel Movement Kinetics, and Patient Tolerability of Same-Day and Split-Dose Bowel Preparation Using 4 L of Polyethylene Glycol: A Prospective Randomized Study. Dis Colon Rectum. 2019 Dec;62(12):1518-1527. doi: 10.1097/DCR.0000000000001499. |
| 30926258 | Background | International Hypoglycaemia Study Group. Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management. Lancet Diabetes Endocrinol. 2019 May;7(5):385-396. doi: 10.1016/S2213-8587(18)30315-2. Epub 2019 Mar 27. |
| 36789141 | Background | Chirila A, Nguyen ME, Tinmouth J, Halperin IJ. Preparing for Colonoscopy in People with Diabetes: A Review with Suggestions for Clinical Practice. J Can Assoc Gastroenterol. 2022 Dec 30;6(1):26-36. doi: 10.1093/jcag/gwac035. eCollection 2023 Feb. |
| 28826680 | Background | Gandhi K, Tofani C, Sokach C, Patel D, Kastenberg D, Daskalakis C. Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):357-369.e10. doi: 10.1016/j.cgh.2017.08.016. Epub 2017 Aug 18. |
| 18978506 | Background | Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442. |
| 11280539 | Background | Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x. |
| 26460222 | Background | Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13. |