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Completed

NCT Number: NCT02300779

Diet for Colonoscopy Preparation in Diabetic Patients

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.

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Key information

Conditions

Diabetes Mellitus Behavior Colonic Diseases Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Intestinal Diseases Metabolic Diseases Nutritional and Metabolic Diseases Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Low-residue diet

Dietary 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 care

Dietary 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.

Primary outcomes

  1. Efficacy of the bowel preparation

    Time frame: 1 hour after the colonoscopy

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

Secondary outcomes

  1. Cecal intubation

    Time frame: 1 hour after the colonoscopy

    Ratio of successful cecal intubations in each study arm

  2. Polyp and adenoma detection

    Time frame: 1 hour after the colonoscopy

    Ratio of polyps and adenomas detected in each study arm

  3. Symptomatic hypoglycemia

    Time frame: 6 hours after finishing bowel preparation

    Each participant will report his/her experience in a questionnaire

  4. Abdominal pain, nausea, hunger and bloating

    Time frame: 6 hours after finishing bowel preparation

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

  5. Adverse events

    Time frame: 30 days after the colonoscopy

    Description of all spontaneously reported adverse events.

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

    Time frame: 6 hours after finishing bowel preparation

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

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

    Time frame: 6 hours after finishing bowel preparation

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

  8. Predictors of inadequate bowel preparation

    Time frame: Baseline

    Independent predictors will be identified by multivariate analysis

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Germans Trias i Pujol Hospital

Registry information

Official study title

Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study

Acronym: DIMEPREP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2014
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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