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

NCT01533688 | Completed Results

• 1 other identifier: 2869
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.

  24 hours

Study Arms (3)

Golytely + placebo

ACTIVE COMPARATOR

4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill

Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo

Golytely Split + placebo

PLACEBO COMPARATOR

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

Golytely Split + Bisacodyl

EXPERIMENTAL

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

Interventions

Golytely (polyethylene glycol electrolyte lavage solution) and placebo DRUG

4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy

Golytely + placebo

split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo DRUG

split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo

Golytely Split + placebo

split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl DRUG

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

Golytely Split + Bisacodyl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult diabetic outpatients referred for elective colonoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Golytely; Bisacodyl

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Mohammad Madhoun
• Organization: UOklahoma

mohammad-madhoun@ouhsc.edu

405-456-326-

Study Officials

• Mohammad Madhoun, MD

  University of Oklahoma Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 15, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 7, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-08

Locations

US (1)