Diabetes MellitusNCT01533688
Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients
A study testing split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl in people with Diabetes Mellitus, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult diabetic outpatients referred for elective colonoscopy
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma VA Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial
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
- Being tested
- Golytely (polyethylene glycol electrolyte lavage solution) and placebo, split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo, split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golytely (polyethylene glycol electrolyte lavage solution) and placeboDrug
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placeboDrug
split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodylDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Golytely + placebo | Active comparator | 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill Receives: 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 Receives: 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 Receives: Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.
Number of Participants Who Developed Side Effects of Taking Bowel Preparations
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Madhoun, MD, Principal investigator, University of Oklahoma Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533688
- Sponsor's protocol ID
- 2869
- Status last verified
- Aug 2018
- First submitted
- 19 Jan 2012
- Last updated
- 7 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01533688
- Acronym / sponsor ID
- 2869
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Golytely + placebo | Active comparator | Drug: Golytely (polyethylene glycol electrolyte lavage solution) and placebo4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill |
| Golytely Split + placebo | Placebo comparator | Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebosplit dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill |
| Golytely Split + Bisacodyl | Experimental | Drug: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodylsplit dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult diabetic outpatients referred for elective colonoscopy
Key exclusion criteria (12 listed)
- patients < 18 years of age or > 75 yrs of age,
- known or suspected pregnancy,
- known or suspected renal failure,
- unstable angina,
- acute coronary syndrome,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golytely (polyethylene glycol electrolyte lavage solution) and placebo4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy | Drug | Golytely + placebo |
| split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebosplit dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo | Drug | Golytely Split + placebo |
| split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodylsplit dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg | Drug | Golytely Split + Bisacodyl |
Primary outcome
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
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.
1 secondary outcome
Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Madhoun, MD principal investigator
University of Oklahoma Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl in people with Diabetes Mellitus, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.