Diet for Colonoscopy Preparation in Diabetic Patients

Diabetes Mellitus Clinical Trial

— DIMEPREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300779
• Other study ID #: DIMEPREP/PSM/2014
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2014
• Last updated: April 11, 2016
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colonic Diseases
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442. — View Citation

Ozturk NA, Gokturk HS, Demir M, Erdogan D, Unler GK, Gur G, Yilmaz U. The effect of autonomous neuropathy on bowel preparation in type 2 diabetes mellitus. Int J Colorectal Dis. 2009 Dec;24(12):1407-12. doi: 10.1007/s00384-009-0757-4. Epub 2009 Jul 7. — View Citation

Taylor C, Schubert ML. Decreased efficacy of polyethylene glycol lavage solution (golytely) in the preparation of diabetic patients for outpatient colonoscopy: a prospective and blinded study. Am J Gastroenterol. 2001 Mar;96(3):710-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the bowel preparation	Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist	1 hour after the colonoscopy	No
Secondary	Cecal intubation	Ratio of successful cecal intubations in each study arm	1 hour after the colonoscopy	No
Secondary	Polyp and adenoma detection	Ratio of polyps and adenomas detected in each study arm	1 hour after the colonoscopy	No
Secondary	Symptomatic hypoglycemia	Each participant will report his/her experience in a questionnaire	6 hours after finishing bowel preparation	No
Secondary	Abdominal pain, nausea, hunger and bloating	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation	No
Secondary	Adverse events	Description of all spontaneously reported adverse events.	30 days after the colonoscopy	No
Secondary	Adherence to the planned bowel cleansing method (questionnaire)	Each participant will rate his/her experience in a questionnaire.	6 hours after finishing bowel preparation	No
Secondary	Acceptability of the preparation (interference with work, leisure activities or sleep	Each participant will rate his/her experience in a questionnaire.	6 hours after finishing bowel preparation	No
Secondary	Predictors of inadequate bowel preparation	Independent predictors will be identified by multivariate analysis	Baseline	No