Colonoscopy Preparation for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to prepare individuals with diabetes for a colonoscopy, a procedure that examines the colon for issues. People with diabetes often struggle with standard preparation, which can lead to missed problems and low blood sugar (hypoglycemia) due to dietary changes. The trial compares a new, diabetes-friendly method called the Diabetic Specific Protocol, which permits a low-fiber diet before the procedure and alters the timing of the colon cleansing drink, against the standard preparation. This study targets individuals diagnosed with either Type 1 or Type 2 diabetes who can read and understand English. As an unphased trial, it offers a unique opportunity to improve colonoscopy preparation for people with diabetes.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves changes in diet and possibly antihyperglycemic medications, it's best to discuss this with the trial team or your doctor.
What prior data suggests that this diabetic specific protocol is safe for colonoscopy preparation?
Research shows that people with diabetes often face more challenges when preparing for a colonoscopy. They may not clean out their bowels effectively and can experience low blood sugar due to dietary changes. Studies have found that a special plan for people with diabetes, which includes a low-fiber diet and same-day preparation, can help. This plan aims to minimize diet changes and reduce risks while ensuring proper bowel cleansing.
Safety information suggests that this method might be easier for people with diabetes to manage. It helps maintain more stable blood sugar levels compared to traditional methods that require longer fasting and different dietary changes. Although specific side effects are not detailed, the focus on blood sugar stability and allowing some normal eating before the procedure indicates a design to lower known risks.12345Why are researchers excited about this trial?
Researchers are excited about the diabetes-specific colonoscopy preparation protocol because it offers a tailored approach for individuals with diabetes, addressing their unique dietary needs. Unlike the standard preparation, which involves a clear-liquid diet and the intake of polyethylene glycol (PEG) the night before the procedure, this protocol allows patients to follow a low-fiber carbohydrate diet for four days and permits dinner the night before. This approach aims to improve patient comfort and compliance by accommodating their dietary restrictions and potentially minimizing blood sugar fluctuations.
What evidence suggests that this diabetic specific protocol is effective for colonoscopy preparation?
Research has shown that people with diabetes often face more challenges in preparing for colonoscopies than those without diabetes. This difficulty can prolong the procedure and increase the risk of missing polyps. In this trial, participants in the Diabetes-Specific Protocol Group will follow a special preparation plan, which includes a low-fiber diet and same-day preparation. Studies have found that such a plan can significantly improve bowel cleanliness. Specifically, one study found that this method reduced poor preparation rates from 20% to 7%. Another study showed that 70% of diabetic patients using this plan had good preparation compared to 54% using standard methods. This suggests that the diabetes-specific plan could lead to better preparation and fewer risks during colonoscopies for diabetic patients.12467
Are You a Good Fit for This Trial?
This trial is for adults with type 1 or type 2 diabetes who can read English and need a colonoscopy. People can't join if they've had certain bowel surgeries, inflammatory bowel disease, severe kidney problems, recent heart attack, are pregnant or breastfeeding, have allergies to prep ingredients, or other serious health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dietary Preparation
Participants follow a specific dietary protocol prior to colonoscopy. Control group follows a clear-liquid diet after breakfast the day before colonoscopy. Experimental group follows a four-day, low-fiber carbohydrate diet.
Bowel Preparation
Participants ingest PEG solution as part of bowel preparation. Control group ingests 2L of PEG the evening before and 2L four hours prior to colonoscopy. Experimental group ingests 2L of PEG between 5:00 AM and 6:00 AM and the remaining 2L between 8:00 AM and 9:00 AM on the day of the procedure.
Colonoscopy and Monitoring
Participants undergo colonoscopy and are monitored for bowel preparation adequacy and hypoglycemic events.
Follow-up
Participants are monitored for safety and effectiveness after the colonoscopy, including patient-reported ratings of convenience, tolerability, and adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- Diabetic Specific Protocol
Trial Overview
The study compares a new colonoscopy prep plan made for people with diabetes (allowing a low-fiber diet the day before and same-day cleansing) against the usual split-dose prep. The goal is to see which method leads to better results and fewer blood sugar drops.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Queen's University
Lead Sponsor
Citations
Bowel Preparation for Colonoscopy in Patients with Diabetes ...
Diabetic patients had a worse preparation quality and longer cecal intubation and total procedure time compared to non-diabetic patients. These data suggest ...
2.
endocrinologyadvisor.com
endocrinologyadvisor.com/news/recommendations-issued-for-diabetes-specific-colonoscopy-preparation/Recommendations Issued for Diabetes-Specific ...
In addition, some evidence suggests that patients with diabetes who consume a normal breakfast the day before colonoscopy have improved bowel ...
Preparing for Colonoscopy in People with Diabetes - PMC - NIH
People with diabetes have an increased risk of adverse events during the peri-colonoscopy period, including hypoglycemia, lactic acidosis, ...
Bowel preparation in diabetic patients undergoing ...
Diabetes mellitus is a risk factor for poor bowel preparation in patients who undergo colonoscopy, because of their decreased intestinal ...
Diabetes-specific bowel preparation: evidence synthesis ...
Diabetic patients exhibit significantly higher rates of inadequate bowel preparation (IBP) during colonoscopy compared to non-diabetic populations, ...
Developing a Colonoscopy Preparation Protocol for ...
Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, ...
Antihyperglycemic therapy during colonoscopy preparation ...
Diabetes patients have a higher risk for complications during colonoscopy preparation caused by change of diet, concomitant presence of diabetes ...
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