CClinicalTrials.gg
Not yet recruitingNCT07526103Updated Apr 24, 2026

Developing a Colonoscopy Preparation Protocol for Patients With Diabetes

An interventional study of timing of cleansing and procedure in Hypoglycaemia, Diabete Mellitus and Colonoscopy (Ambulatory Patients), sponsored by Queen's University. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Queen's University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypoglycaemia
  • Diabete Mellitus
  • Colonoscopy (Ambulatory Patients)

Keywords

  • glucose monitoring
  • diabetes protocol
  • bowel preparation
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients without diabetes
  2. Patients with prior hospital admission due to hypoglycemic events
  3. Patients who have inflammatory bowel disease
  4. Patients with ileus or bowel obstruction
  5. Patients with history of colorectal resection
  6. Patients receiving combined upper and lower endoscopies
  7. Patients with ascites
  8. Patients with previously documented severe renal impairment
  9. Unable to provide consent
  10. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
  11. Patients who have had a recent myocardial infarction(\<6months)
  12. Allergy to product ingredients
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: timing of cleansing and procedure

  • Experimental
    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.

    Other: timing of cleansing and procedure

Interventions

  • Othertiming of cleansing and procedure

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

05

What researchers measure

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.

    Time frame: During colonoscopy

Secondary outcomes

  1. Glucose Monitoring

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

    Time frame: Pericolonoscopy period

  2. Patient Rating

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

    Time frame: Pericolonoscopy period

06

Study locations

1 site
  • Kingston Health Sciences Centre
    Kingston, Ontario K7L 2V7, Canada
07

References and documents

Publications

  • 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 Apr 6;14:1176206. doi: 10.3389/fphar.2023.1176206. eCollection 2023. PubMed 37089939 ↗
  • 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-Zuniga 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. PubMed 27490086 ↗
  • 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 Dec;62(12):1518-1527. doi: 10.1097/DCR.0000000000001499. PubMed 31567921 ↗
  • International Hypoglycaemia Study Group. Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management. Lancet Diabetes Endocrinol. 2019 May;7(5):385-396. doi: 10.1016/S2213-8587(18)30315-2. Epub 2019 Mar 27. PubMed 30926258 ↗
  • Chirila A, Nguyen ME, Tinmouth J, Halperin IJ. Preparing for Colonoscopy in People with Diabetes: A Review with Suggestions for Clinical Practice. J Can Assoc Gastroenterol. 2022 Dec 30;6(1):26-36. doi: 10.1093/jcag/gwac035. eCollection 2023 Feb. PubMed 36789141 ↗
  • Gandhi K, Tofani C, Sokach C, Patel D, Kastenberg D, Daskalakis C. Patient Characteristics Associated With Quality of Colonoscopy Preparation: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):357-369.e10. doi: 10.1016/j.cgh.2017.08.016. Epub 2017 Aug 18. PubMed 28826680 ↗
  • Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442. PubMed 18978506 ↗
  • Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x. PubMed 11280539 ↗
  • 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. PubMed 26460222 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07526103
Lead sponsor
Queen's University
Responsible party
Lawrence Charles Hookey (Gastroenterologist, Division Chair, Professor, Queen's University) — Principal investigator
First posted
Apr 13, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Apr 24, 2026

Study contacts

Lawrence Hookey, MD
Contact
lawrence.hookey@kingstonhsc.ca
613 544 3400 ext. 2292
Amani Khan, MD
Contact
amani.khan@kingstonhsc.ca
647 628 9700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion