Developing a Colonoscopy Preparation Protocol for Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bowel Preparation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Age over the age of 18
- •Able to read and understand the English language
- •Confirmed diagnosis of diabetes (Type 1 or Type 2)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: timing of cleansing and procedure (Other)
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.
干预措施: timing of cleansing and procedure (Other)
结局指标
主要结局
Bowel Preparation
时间窗: During colonoscopy
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.
次要结局
- Glucose Monitoring(Pericolonoscopy period)
- Patient Rating(Pericolonoscopy period)
研究者
Lawrence Charles Hookey
Gastroenterologist, Division Chair, Professor
Queen's University