Diabetes Mellitus
Conditions
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.
Interventions
DRUGGolytely (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
DRUGsplit 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
DRUGsplit 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
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | 24 hours | Number of Participants Who Developed Side Effects of Taking Bowel Preparations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Golytely + Placebo 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
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 | 63 |
| Golytely Split + Placebo split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
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 | 60 |
| 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
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 | 63 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Had colonoscopy at outside hospital | 2 | 3 | 2 |
| Overall Study | Medically unstable | 1 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Golytely + Placebo | Golytely Split + Placebo | Golytely Split + Bisacodyl |
|---|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 6.8 | 64.7 years STANDARD_DEVIATION 6.4 | 62.8 years STANDARD_DEVIATION 7.2 | 63.2 years STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized Other | 49 Participants | 22 Participants | 15 Participants | 12 Participants |
| Race/Ethnicity, Customized White race | 137 Participants | 41 Participants | 45 Participants | 51 Participants |
| Region of Enrollment United States | 186 Participants | 63 Participants | 60 Participants | 63 Participants |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 178 Participants | 61 Participants | 59 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 63 | 27 / 60 | 28 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 60 | 0 / 63 |
Outcome results
Primary
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.
Time frame: Day 1
Population: We have missing data regarding reporting of Boston bowel preparation scores (BBPS), some providers didn't provide the BBPS and provided only subjective assessment of the bowel preparation (for example, good or excellent)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Golytely + Placebo | 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. | 42 Participants |
| Golytely Split + Placebo | 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. | 50 Participants |
| Golytely Split + Bisacodyl | 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. | 47 Participants |
Secondary
Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.
Number of Participants Who Developed Side Effects of Taking Bowel Preparations
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Golytely + Placebo | Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | 24 Participants |
| Golytely Split + Placebo | Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | 28 Participants |
| Golytely Split + Bisacodyl | Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | 28 Participants |