Clinical trial NCT02300779: Diet for Colonoscopy Preparation in Diabetic Patients
Official title: Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Colonic Diseases
Keywords: Colonoscopy
Diabetes Mellitus
Diet
Polyethylene glycols
Efficacy
Personal satisfaction
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
First posted: 2014-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for colonoscopy in diabetic patients.

Detailed description: Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to follow one of two different sets of dietary recommendations. The experimental group will be asked to start a low-residue diet 4 days before the procedure, during which the therapy for diabetes will be adjusted. The control group will be asked to follow a low-residue diet for 3 days followed by a liquid diet during the day before the procedure, and no adjustments will be made to their usual treatment.

Colon cleansing will be undertaken with polyethylene glycol (4 liters in the usual split administration scheme) in both groups.

Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
* Diabetes mellitus (being treated with insulin or any oral agent).

Exclusion Criteria:

* Unwillingness to participate.
* Hospital admission at the time of colonoscopy.
* Inability to follow instructions
* Active inflammatory bowel disease
* Previous colectomy.
* Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist

Primary outcomes:
measure: Efficacy of the bowel preparation
timeFrame: 1 hour after the colonoscopy
Secondary outcomes:
measure: Cecal intubation
timeFrame: 1 hour after the colonoscopy
measure: Polyp and adenoma detection
timeFrame: 1 hour after the colonoscopy
measure: Symptomatic hypoglycemia
timeFrame: 6 hours after finishing bowel preparation
measure: Abdominal pain, nausea, hunger and bloating
timeFrame: 6 hours after finishing bowel preparation
measure: Adverse events
timeFrame: 30 days after the colonoscopy
measure: Adherence to the planned bowel cleansing method (questionnaire)
timeFrame: 6 hours after finishing bowel preparation
measure: Acceptability of the preparation (interference with work, leisure activities or sleep
timeFrame: 6 hours after finishing bowel preparation
measure: Predictors of inadequate bowel preparation
timeFrame: Baseline
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar
name: Marco Antonio Alvarez González, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ozturk NA, Gokturk HS, Demir M, Erdogan D, Unler GK, Gur G, Yilmaz U. The effect of autonomous neuropathy on bowel preparation in type 2 diabetes mellitus. Int J Colorectal Dis. 2009 Dec;24(12):1407-12. doi: 10.1007/s00384-009-0757-4. Epub 2009 Jul 7.
citation: 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.
citation: 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.