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NCT Number: NCT07526103

Developing a Colonoscopy Preparation Protocol for Patients With Diabetes

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location contact

KHSC Hotel Dieu Colonoscopy Suite

CONTACT

[email protected]

613-548-2342

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

timing of cleansing and procedure

Other

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

Primary outcomes

  1. Bowel Preparation

    Time frame: 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.

Secondary outcomes

  1. Glucose Monitoring

    Time frame: Pericolonoscopy period

    Evaluating the incidence of hypoglycemic events (blood glucose <3.9 mmol/L) from the initiation of bowel preparation until discharge from colonoscopy suite.

  2. Patient Rating

    Time frame: Pericolonoscopy period

    Patient-reported ratings of convenience, tolerability and adverse events associated with the preparation protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Amani Khan, MD

CONTACT

[email protected]

647 628 9700

Lawrence Hookey, MD

CONTACT

[email protected]

613 544 3400 ext. 2292

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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