Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients

Study Overview
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Brief Summary
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Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.

Official Title
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Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo
* Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo
* Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult diabetic outpatients referred for elective colonoscopy Exclusion Criteria: patients < 18 years of age or > 75 yrs of age, known or suspected pregnancy, known or suspected renal failure, unstable angina, acute coronary syndrome, decompensated congestive heart failure, decompensated liver failure, known or suspected bowel obstruction, major psychiatric illness, solid organ transplant patients, known allergies to PEG-ELS or bisacodyl, prior alimentary tract surgery or refusal to consent to the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Golytely + placebo<br>4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill | Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo<br>* 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy<br>|
| Placebo Comparator: Golytely Split + placebo<br>split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill | Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo<br>* split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo<br>|
| Experimental: Golytely Split + Bisacodyl<br>split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg | Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl<br>* split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. | The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | Number of Participants Who Developed Side Effects of Taking Bowel Preparations | 24 hours |