Diet for Colonoscopy Preparation in Diabetic Patients

Phase 3

Completed

• Conditions: Colonic Diseases; Diabetes Mellitus
• Interventions: Dietary Supplement: Low-residue diet; Dietary Supplement: Usual care

• Registration Number: NCT02300779
• Lead Sponsor: Parc de Salut Mar

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

Study Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Study Start: 2014-12
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-residue diet	Low-residue diet	Subjects will follow a low-residue diet for 4 days. Their usual treatment for diabetes will be adjusted to the degree of glycemic control.
Usual care	Usual care	Subjects will follow a low-residue diet for 3 days (from 4 to 2 days before the procedure) and a liquid diet on the following day (the one before the procedure). No changes in their treatment for diabetes will be made

Primary Outcome Measures

Name	Time	Method
Efficacy of the bowel preparation	1 hour after the colonoscopy	Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist

Secondary Outcome Measures

Name	Time	Method
Acceptability of the preparation (interference with work, leisure activities or sleep	6 hours after finishing bowel preparation	Each participant will rate his/her experience in a questionnaire.
Predictors of inadequate bowel preparation	Baseline	Independent predictors will be identified by multivariate analysis
Polyp and adenoma detection	1 hour after the colonoscopy	Ratio of polyps and adenomas detected in each study arm
Adverse events	30 days after the colonoscopy	Description of all spontaneously reported adverse events.
Cecal intubation	1 hour after the colonoscopy	Ratio of successful cecal intubations in each study arm
Abdominal pain, nausea, hunger and bloating	6 hours after finishing bowel preparation	Each participant will rate his/her experience in an analogue visual scale
Adherence to the planned bowel cleansing method (questionnaire)	6 hours after finishing bowel preparation	Each participant will rate his/her experience in a questionnaire.
Symptomatic hypoglycemia	6 hours after finishing bowel preparation	Each participant will report his/her experience in a questionnaire

Trial Locations

Locations (2)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain