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Diet for Colonoscopy Preparation in Diabetic Patients (DIMEPREP)

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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Colonic Diseases Dietary Supplement: Low-residue diet Dietary Supplement: Usual care Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study
Study Start Date : December 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.


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
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300779


Locations
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Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Marco Antonio Alvarez González, MD, PhD Parc de Salut Mar

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marco Antonio Alvarez Gonzalez, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02300779     History of Changes
Other Study ID Numbers: DIMEPREP/PSM/2014
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Keywords provided by Marco Antonio Alvarez Gonzalez, Parc de Salut Mar:
Colonoscopy
Diabetes Mellitus
Diet
Polyethylene glycols
Efficacy
Personal satisfaction

Additional relevant MeSH terms:
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Diabetes Mellitus
Colonic Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases