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Diet for Colonoscopy Preparation in Diabetic Patients

NCT02300779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-04-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Marco Antonio Alvarez González, MD, PhD · Parc de Salut Mar

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-07-31
Completion
2015-10-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300779 on ClinicalTrials.gov