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Diet for Colonoscopy Preparation in Diabetic Patients (DIMEPREP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300779
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : April 12, 2016
Sponsor:
Collaborator:
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
Marco Antonio Alvarez Gonzalez, Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date April 12, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
Efficacy of the bowel preparation [ Time Frame: 1 hour after the colonoscopy ]
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
  • Cecal intubation [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of successful cecal intubations in each study arm
  • Polyp and adenoma detection [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of polyps and adenomas detected in each study arm
  • Symptomatic hypoglycemia [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will report his/her experience in a questionnaire
  • 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
  • Adverse events [ Time Frame: 30 days after the colonoscopy ]
    Description of all spontaneously reported adverse events.
  • 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.
  • 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.
  • Predictors of inadequate bowel preparation [ Time Frame: Baseline ]
    Independent predictors will be identified by multivariate analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet for Colonoscopy Preparation in Diabetic Patients
Official Title  ICMJE Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study
Brief 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes Mellitus
  • Colonic Diseases
Intervention  ICMJE
  • Dietary Supplement: Low-residue diet

    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.

  • Dietary Supplement: Usual care

    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 Arms  ICMJE
  • Experimental: Low-residue diet
    Subjects will follow a low-residue diet for 4 days. Their usual treatment for diabetes will be adjusted to the degree of glycemic control.
    Intervention: Dietary Supplement: Low-residue diet
  • Active Comparator: Usual care
    Subjects 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
    Intervention: Dietary Supplement: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300779
Other Study ID Numbers  ICMJE DIMEPREP/PSM/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Antonio Alvarez Gonzalez, Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Germans Trias i Pujol Hospital
Investigators  ICMJE
Principal Investigator: Marco Antonio Alvarez González, MD, PhD Parc de Salut Mar
PRS Account Parc de Salut Mar
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP