Colonoscopy Preparation for Diabetes

LH
AK
Overseen ByAmani Khan, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to read and understand the English language
I have been diagnosed with diabetes.
I am over 18 years old.

Exclusion Criteria

I have had part of my colon or rectum surgically removed.
I have inflammatory bowel disease.
I have a blockage in my bowel or intestines.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4 days

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.

1 day

Colonoscopy and Monitoring

Participants undergo colonoscopy and are monitored for bowel preparation adequacy and hypoglycemic events.

During colonoscopy

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy, including patient-reported ratings of convenience, tolerability, and adverse events.

Pericolonoscopy period

What Are the Treatments Tested in This Trial?

Interventions

  • Diabetic Specific Protocol

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Diabetes-Specific Protocol GroupExperimental Treatment1 Intervention
Group II: Control Group (Standard Preparation)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials
382
Recruited
122,000+