Diet for Colonoscopy Preparation in Diabetic Patients (DIMEPREP)

Parc de Salut Mar

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus; Colonic Diseases

Treatments: Dietary Supplement: Usual care; Dietary Supplement: Low-residue diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02300779

DIMEPREP/PSM/2014

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Low-residue diet

Experimental group

Description:

Subjects will follow a low-residue diet for 4 days. Their usual treatment for diabetes will be adjusted to the degree of glycemic control.

Treatment:

Dietary Supplement: Low-residue diet

Usual care

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Usual care