Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients
This study is currently recruiting participants.
Verified February 2012 by University of Oklahoma
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01533688
First received: January 19, 2012
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus |
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- 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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 7 or more, rated by blinded colonoscopist.
Secondary Outcome Measures:
- Measure of patients who develop (tolerance)side effects of taking bowel preparations. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Tolerability of the bowel prep will be measured by the number/% of participants with adverse events(i.e. nausea,vomiting, abdominal pain, bloating or rectal burning sensation) using a survey.
| Estimated Enrollment: | 244 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Golytely + placebo
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
|
Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
|
|
Placebo Comparator: Golytely Split + placebo
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
split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
|
|
Experimental: Golytely Split + Bisacodyl
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
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533688
Contacts
| Contact: Sian Chisholm, MD | 405-271-5428 |
Locations
| United States, Oklahoma | |
| Oklahoma VA Medical Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: Mohammad Madhoun, MD | |
Sponsors and Collaborators
University of Oklahoma
Investigators
| Principal Investigator: | Mohammad Madhoun, MD | University of Oklahoma Health Science Center |
More Information
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01533688 History of Changes |
| Other Study ID Numbers: | OU IRB 16121 |
| Study First Received: | January 19, 2012 |
| Last Updated: | February 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bisacodyl |
Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013