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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Bisacodyl
Pharmaceutical Solutions
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014