Diet for Colonoscopy Preparation in Diabetic Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study

Conditions
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Diabetes Mellitus, Colonic Diseases

Intervention / Treatment
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* Dietary Supplement: Low-residue diet
* Dietary Supplement: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-residue diet<br>Subjects will follow a low-residue diet for 4 days. Their usual treatment for diabetes will be adjusted to the degree of glycemic control. | Dietary Supplement: Low-residue diet<br>* Subjects will be instructed by members of the research team to follow a low-residue diet for 4 days. Bowel cleansing will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the bowel cleansing is complete. Their usual treatment for diabetes (whether insulin or an oral agent) will be adjusted.<br>|
| Active Comparator: Usual care<br>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 | Dietary Supplement: Usual care<br>* Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by a liquid-only diet for an additional day. Bowel cleansing will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the bowel cleansing is complete. No modifications in their usual treatment will be made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the bowel preparation | Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist | 1 hour after the colonoscopy | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Diabetes Mellitus, Diet, Polyethylene glycols, Efficacy, Personal satisfaction