AzTrials
AzTrials

Diabetes MellitusPhase 3iDIMEPREPNCT02297399

Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

A Phase 3 study testing PEG-ascorbate 2L and PEG 4L in people with Diabetes Mellitus and Colonic Diseases, run by Parc de Salut Mar at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Colonic Diseases
What is being tested?
PEG-ascorbate 2L and PEG 4L
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
2 sitesSpain
Study dates
2 Dec 2014to 26 Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
  • Diabetes mellitus (being treated with insulin or any oral agent).

Who cannot join

  • Unwillingness to participate.
  • Hospital admission at the time of colonoscopy.
  • Inability to follow instructions
  • Active inflammatory bowel disease
  • Previous colectomy.
  • Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, Barcelona, 08003

Other trials in Spain

About this study

Official title: Improvement of Tolerability for Bowel Preparation for Colonoscopy in Diabetic Patients. A Randomized Controlled Trial of Two Bowel Preparation Protocols Including 4 Liters PEG vs. 2 Liters PEG Plus Ascorbic Acid. iDIMEPREP Study.

This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.

Read the detailed description

Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to 2 different methods of colon cleansing before the procedure.

Both will be based on the oral ingestion of a fluid solution (half of it on the evening before the procedure is planned and the rest on the morning of the same day), and the main difference between them will be the volume of fluid that will be ingested in each case.

Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure

Being tested
PEG-ascorbate 2L, PEG 4L
Keywords
Colonoscopy, Diabetes Mellitus, Polyethylene glycols, Ascorbate, Personal satisfaction
Medical subject headings
Diabetes Mellitus, Colonic Diseases, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-ascorbate 2LDrug

    Also called Moviprep®

    Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.

    Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 2 sachets (labelled A and B) of the investigational product and take their contents diluted in 1 liter of water. Two other sachets, also labelled A and B, will be taken diluted in 1 liter of water 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.

  • PEG 4LDrug

    Also called Bohm®

    Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.

    Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.

Study groups in NCT02297399
Study groupRoleWhat they receive
PEG-ascorbate 2LExperimentalSubjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.
Receives: Drug: PEG-ascorbate 2L
PEG 4LActive comparatorSubjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
Receives: Drug: PEG 4L

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability of the bowel preparation (analogue visual scale)

    Each participant will rate his/her experience in an analogue visual scale.

    Measured: 6 hours after finishing bowel preparation

Secondary outcomes (6)

  1. Ease of consumption and taste of the laxative (analogue visual scale)

    Each participant will rate his/her experience in an analogue visual scale.

    Measured: 6 hours after finishing bowel preparation

  2. Abdominal pain, nausea and bloating (analogue visual scale)

    Each participant will rate his/her experience in an analogue visual scale.

    Measured: 6 hours after finishing bowel preparation

  3. Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)

    Each participant will rate his/her experience in a questionnaire.

    Measured: 6 hours after finishing bowel preparation

  4. Adherence to the planned bowel cleansing method (questionnaire)

    Each participant will rate his/her experience in a questionnaire.

    Measured: 6 hours after finishing bowel preparation

  5. Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)

    Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist

    Measured: 10 minutes after the colonoscopy

  6. Adverse events

    Description of any adverse event occurred during the study period

    Measured: 30 days after the colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study start2 Dec 2014
  3. Primary completion26 Jan 2016
  4. Study completion26 Jan 2016

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297399
Sponsor's protocol ID
4790-I
Acronym
iDIMEPREP
Status last verified
Feb 2017
First submitted
13 Nov 2014
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Hsu CW, Imperiale TF. Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation. Gastrointest Endosc. 1998 Sep;48(3):276-82. doi: 10.1016/s0016-5107(98)70191-9.

    PubMed 9744604

  • Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.

    PubMed 10968848

  • Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. doi: 10.1111/j.1572-0241.2001.03610.x.

    PubMed 11280539

  • Ozturk NA, Gokturk HS, Demir M, Erdogan D, Unler GK, Gur G, Yilmaz U. The effect of autonomous neuropathy on bowel preparation in type 2 diabetes mellitus. Int J Colorectal Dis. 2009 Dec;24(12):1407-12. doi: 10.1007/s00384-009-0757-4. Epub 2009 Jul 7.

    PubMed 19582466

  • Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Runzi M, Schneider T, Kachel G, Gruger J, Kollinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008 Apr;103(4):883-93. doi: 10.1111/j.1572-0241.2007.01708.x. Epub 2008 Jan 11.

    PubMed 18190651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEG-ascorbate 2L and PEG 4L in people with Diabetes Mellitus and Colonic Diseases, run by Parc de Salut Mar at 2 sites in Spain.

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 2 inclusion and 6 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tolerability of the bowel preparation (analogue visual scale) (time frame: 6 hours after finishing bowel preparation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297399, which also lists 5 linked publications.

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 23 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in