A Phase 3 interventional study of Low-residue diet and Usual care in Diabetes Mellitus and Colonic Diseases, sponsored by Parc de Salut Mar. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-12.
Sponsored by Parc de Salut Mar · Phase 3, Interventional, and Supportive care
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.
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
142 studies on the registry are indexed under Colonic Diseases; 22 are open to participants now.
This study's enrollment of 150 is close to the median of 143 across 93 interventional studies indexed under Colonic Diseases.
Browse Colonic Diseases studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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.
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.
Efficacy of the bowel preparation
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
Time frame: 1 hour after the colonoscopy
Cecal intubation
Ratio of successful cecal intubations in each study arm
Time frame: 1 hour after the colonoscopy
Polyp and adenoma detection
Ratio of polyps and adenomas detected in each study arm
Time frame: 1 hour after the colonoscopy
Symptomatic hypoglycemia
Each participant will report his/her experience in a questionnaire
Time frame: 6 hours after finishing bowel preparation
Abdominal pain, nausea, hunger and bloating
Each participant will rate his/her experience in an analogue visual scale
Time frame: 6 hours after finishing bowel preparation
Adverse events
Description of all spontaneously reported adverse events.
Time frame: 30 days after the colonoscopy
Adherence to the planned bowel cleansing method (questionnaire)
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation
Predictors of inadequate bowel preparation
Independent predictors will be identified by multivariate analysis
Time frame: Baseline
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar