NCT07526103

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 6, 2026

Last Update Submit

April 21, 2026

Conditions

HypoglycaemiaDiabete MellitusColonoscopy (Ambulatory Patients)

Keywords

glucose monitoringdiabetes protocolbowel preparation

Outcome Measures

Primary Outcomes (1)

  • Bowel Preparation

    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.

    During colonoscopy

Secondary Outcomes (2)

  • Glucose Monitoring

    Pericolonoscopy period

  • Patient Rating

    Pericolonoscopy period

Study Arms (2)

Control Group (Standard Preparation)

ACTIVE COMPARATOR

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.

Other: timing of cleansing and procedure

Diabetes-Specific Protocol Group

EXPERIMENTAL

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.

Other: timing of cleansing and procedure

Interventions

timing of cleansing and procedureOTHER

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

Control Group (Standard Preparation)Diabetes-Specific Protocol Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (9)

  • 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;14:1176206.

    BACKGROUND

  • 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-Zuñiga 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.

    BACKGROUND

  • 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;62(12):1518-27.

    BACKGROUND

  • International Hypoglycaemia Study Group. Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management [published correction appears in Lancet Diabetes Endocrinol. 2019 Jun;7(6):e18]. Lancet Diabetes Endocrinol. 2019;7(5):385-396. doi: 10.1016/S2213-8587(18)30315-2

    BACKGROUND

  • Alexandra Chirila, Mary E Nguyen, Jill Tinmouth, Ilana J Halperin, Preparing for Colonoscopy in People with Diabetes: A Review with Suggestions for Clinical Practice, Journal of the Canadian Association of Gastroenterology, Volume 6, Issue 1, February 2023, Pages 26-36

    BACKGROUND

  • Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis. Gandhi K, Tofani C, Sokach C, Patel D, Kastenberg D, Daskalakis C. Clin Gastroenterol Hepatol. 2018 Mar;16(3):357-369.e10. doi: 10.1016/j.cgh.2017.08.016. Epub 2017 Aug 18.

    BACKGROUND

  • Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, et al. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. Journal of Clinical Gastroenterology. 2009;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442 18978506.

    BACKGROUND

  • Taylor C., Schubert M. L. (2001). Decreased efficacy of polyethylene glycol lavage solution (Golytely) in the preparation of diabetic patients for outpatient colonoscopy: A prospective and blinded study. American Journal of Gastroenterology, 96(3), 710-714.

    BACKGROUND

  • Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta- analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13. PMID: 26460222.

    BACKGROUND

MeSH Terms

Conditions

HypoglycemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Lawrence Hookey, MD

CONTACT

613 544 3400lawrence.hookey@kingstonhsc.ca

Amani Khan, MD

CONTACT

647 628 9700amani.khan@kingstonhsc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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. Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device. 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.Glucose will be monitored throughout the pericolonoscopy period via continuous glucose monitoring device.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist, Division Chair, Professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)