Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
Colonoscopy, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Cleansing, Preparation, PEG, Quality
Brief summary
A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p\<0.001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint. We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics.
Detailed description
STUDY DESIGN This is an investigator-initiated, single site (MCG only), single-blinded prospective study comparing the efficacy of Lubiprostone and 4L PEG (Nulytely) to 4 Liters (4L) PEG alone on preparation quality in patients with known diabetes undergoing colonoscopy. Diabetic outpatients who require a colonoscopy will be randomized to one of the two groups of 60 (total of 120 patients): Control Group: All patients in the study will receive a standard oral 4L PEG colonoscopy preparation the day prior to their scheduled colonoscopy. Lubiprostone Group: The lubiprostone group will receive an additional two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the oral 4L PEG preparation). Randomization Scheme: Subjects will be assigned to the Control Group or Lubiprostone Group, on an odd/even basis. After research informed consent has been obtained, subjects are given a study Identification (ID) numbered 1 through 120. Subjects with an odd number will be assigned to Control Group, and subjects with an even number will be assigned to the Lubiprostone Group. Subjects then will be given a randomization package consisting of the preparation orders, supplies, instructions and the date of their procedure by the investigator obtaining informed consent. The colonoscopist will be blinded to which preparation was given. Only diabetic patients who require an outpatient colonoscopy by a gastroenterologist at the outpatient MCG Clinic will be eligible for the study. Patients will be presented with a separate consent form for the colonoscopy procedure itself. Standard of Care Procedures * Colonoscopy Procedure Consent * Colonoscopy Study Procedures * Research Informed Consent * Disbursement of randomized preparation order and supplies, instructions, and date of procedure to subjects * Adverse Events After the procedure, the physician who performed the colonoscopy will complete a form that rates the quality of the subject's colonoscopy preparation on a 1-5 rating scale. The subject's study participation duration is two days (day of preparation and day of procedure). No follow-up visits will occur.
Interventions
DRUGLubiprostone
Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep).
Standard oral dosing of 4L Polyethylene glycol colonoscopy preparation the day prior to their scheduled colonoscopy.
Sponsors
Takeda Pharmaceuticals North America, Inc.
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with known diabetes (type I or II) undergoing elective colonoscopy at the Medical College of Georgia. * Patients aged 50 years and older. * Women must be post-menopausal or surgically sterile. * Patients able to give a valid, informed consent.
Exclusion criteria
* Patients with impaired glucose tolerance. * Patients with suspected acute or chronic pseudo-obstruction. * Patients with active gastrointestinal bleeding. * Patients with known inflammatory bowel disease. * Patients with chronic diarrhea. * Patients with prior colonic resection. * Patients with active diverticulitis. * Patients with a known colonic mass. * Patients with clinical evidence of decompensated liver disease. * Patients with clinical evidence of decompensated renal disease or patients on dialysis. * Patients currently or previously taking lubiprostone. * Patients with an allergy to lubiprostone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale. | The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours | The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial. |
Countries
United States
Participant flow
Recruitment details
Study participation was offered to all adult-onset diabetic outpatients 50 and over who were referred to the Gastroenterology clinic at the Medical College of Georgia in Augusta, Georgia for a screening colonoscopy from July, 2008 to March, 2010.
Participants by arm
| Arm | Count |
|---|---|
| Experimental PEG plus lubiprostone colon cleansing | 30 |
| Control PEG colon cleansing | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 13 | 6 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 8 | 55 years STANDARD_DEVIATION 7 | 58.5 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 0 / 24 |
| serious Total, serious adverse events | 0 / 17 | 0 / 24 |
Outcome results
Primary
The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.
The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.
Time frame: The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours
Population: 13 patients were excluded from the Experimental Arm (12 cancelled their appointment and 1 did not complete the prep) and 6 were excluded from the Control Arm (5 cancelled their procedure and 1 withdrew from the trial) therefore results were analyzed and compared using the chi-square statistics-Validated Aronchik colonoscopy cleansing grading scale.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale. | 47 percentage of patients |
| Control | The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale. | 25 percentage of patients |