Developing a Colonoscopy Preparation Protocol for Patients With Diabetes

Обзор

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.

Вмешательства

• Другое timing of cleansing and procedure
  we are altering the timing of colonoscopy and cleansing for colonoscopy for patients with diabetes.

Первичные конечные точки

• Bowel Preparation [Срок оценки: During colonoscopy]

Вторичные конечные точки (2)

• Glucose Monitoring [Срок оценки: Pericolonoscopy period]
• Patient Rating [Срок оценки: Pericolonoscopy period]

Критерии участия

Критерии включения

• Patients Age over the age of 18
• Able to read and understand the English language
• Confirmed diagnosis of diabetes (Type 1 or Type 2)

Критерии исключения

• Patients without diabetes
• Patients with prior hospital admission due to hypoglycemic events
• Patients who have inflammatory bowel disease
• Patients with ileus or bowel obstruction
• Patients with history of colorectal resection
• Patients receiving combined upper and lower endoscopies
• Patients with ascites
• Patients with previously documented severe renal impairment
• Unable to provide consent
• Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
• Patients who have had a recent myocardial infarction(<6months)
• Allergy to product ingredients

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• Kingston Health Sciences Centre — Kingston

Публикации

• 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. PMID 37089939
• 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. PMID 27490086
• 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. PMID 31567921
• 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. PMID 30926258
• 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. PMID 36789141
• 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. PMID 28826680
• 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. PMID 18978506
• 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. PMID 11280539

Идентификаторы

NCT: NCT07526103 · 20253698 · 3698

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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