ClinicalTrials.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

In context

Hypoglycemia

706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.

This study's planned enrollment of 40 is above the median of 28 across 534 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 will undergo urine pregnancy testing)
  11. Patients who have had a recent myocardial infarction(\<6months)
  12. Allergy to product ingredients
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

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.

06

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

07

Study locations

1 site
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2028, 24 months later.

Of 169 non-industry interventional studies with no phase under Hypoglycemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 24 months is above that.

Counting every sponsor, half of 175 studies reached it within 17 months; a quarter within 7 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2026
First posted
Apr 13, 2026
StartEst.
Jun 1, 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Jun 1, 2028
Last update
Apr 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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