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Diabetes MellitusPhase 3DIMEPREPNCT02300779

Diet for Colonoscopy Preparation in Diabetic Patients

A Phase 3 study testing Low-residue diet 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
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Trial summary

This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for 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?
Low-residue diet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesSpain
Study dates
Dec 2014to Oct 2015
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: Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study

This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for colonoscopy in diabetic patients.

Read the detailed description

Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to follow one of two different sets of dietary recommendations. The experimental group will be asked to start a low-residue diet 4 days before the procedure, during which the therapy for diabetes will be adjusted. The control group will be asked to follow a low-residue diet for 3 days followed by a liquid diet during the day before the procedure, and no adjustments will be made to their usual treatment.

Colon cleansing will be undertaken with polyethylene glycol (4 liters in the usual split administration scheme) in both groups.

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
Low-residue diet, Usual care
Keywords
Colonoscopy, Diabetes Mellitus, Diet, Polyethylene glycols, Efficacy, 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.

  • Low-residue dietDietary supplement

    Subjects will be instructed by members of the research team to follow a low-residue diet for 4 days.

    Bowel cleansing 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 bowel cleansing is complete. Their usual treatment for diabetes (whether insulin or an oral agent) will be adjusted.

  • Usual careDietary supplement

    Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by a liquid-only diet for an additional day.

    Bowel cleansing 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 bowel cleansing is complete. No modifications in their usual treatment will be made.

Study groups in NCT02300779
Study groupRoleWhat they receive
Low-residue dietExperimentalSubjects will follow a low-residue diet for 4 days. Their usual treatment for diabetes will be adjusted to the degree of glycemic control.
Receives: Dietary Supplement: Low-residue diet
Usual careActive comparatorSubjects will follow a low-residue diet for 3 days (from 4 to 2 days before the procedure) and a liquid diet on the following day (the one before the procedure). No changes in their treatment for diabetes will be made
Receives: Dietary Supplement: Usual care

What is being measured

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

  1. Efficacy of the bowel preparation

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

    Measured: 1 hour after the colonoscopy

Secondary outcomes (8)

  1. Cecal intubation

    Ratio of successful cecal intubations in each study arm

    Measured: 1 hour after the colonoscopy

  2. Polyp and adenoma detection

    Ratio of polyps and adenomas detected in each study arm

    Measured: 1 hour after the colonoscopy

  3. Symptomatic hypoglycemia

    Each participant will report his/her experience in a questionnaire

    Measured: 6 hours after finishing bowel preparation

  4. Abdominal pain, nausea, hunger and bloating

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

    Measured: 6 hours after finishing bowel preparation

  5. Adverse events

    Description of all spontaneously reported adverse events.

    Measured: 30 days after the colonoscopy

  6. 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

  7. Acceptability of the preparation (interference with work, leisure activities or sleep

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

    Measured: 6 hours after finishing bowel preparation

  8. Predictors of inadequate bowel preparation

    Independent predictors will be identified by multivariate analysis

    Measured: Baseline

Timeline

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

  1. First posted25 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJul 2015
  4. Study completionOct 2015

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02300779
Sponsor's protocol ID
DIMEPREP/PSM/2014
Acronym
DIMEPREP
Status last verified
Apr 2016
First submitted
21 Nov 2014
Last updated
12 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442.

    PubMed 18978506

  • Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4.

    PubMed 27490086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low-residue diet 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 12 Apr 2016. 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?

Efficacy of the bowel preparation (time frame: 1 hour after the colonoscopy). 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 NCT02300779, which also lists 4 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 12 Apr 2016.

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