Diet for Colonoscopy Preparation in Diabetic Patients

NCT02300779 | Completed Phase 3

• 1 other identifier: DIMEPREP/PSM/2014
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Colonic Diseases

Keywords

Colonoscopy; Diabetes Mellitus; Diet; Polyethylene glycols; Efficacy; Personal satisfaction

Outcome Measures

Primary Outcomes (1)

• Efficacy of the bowel preparation

  Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist

  1 hour after the colonoscopy

Secondary Outcomes (8)

• Cecal intubation

  1 hour after the colonoscopy

• Polyp and adenoma detection

  1 hour after the colonoscopy

• Symptomatic hypoglycemia

  6 hours after finishing bowel preparation

• Abdominal pain, nausea, hunger and bloating

  6 hours after finishing bowel preparation

• Adverse events

  30 days after the colonoscopy

Study Arms (2)

Low-residue diet

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Low-residue diet DIETARY_SUPPLEMENT

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.

Low-residue diet

Usual care DIETARY_SUPPLEMENT

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
• Diabetes mellitus (being treated with insulin or any oral agent).

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (2)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (4)

• 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. doi: 10.1111/j.1572-0241.2001.03610.x.

  PMID: 11280539 BACKGROUND

• 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.

  PMID: 19582466 BACKGROUND

• 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.

  PMID: 18978506 BACKGROUND

• Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4.

  PMID: 27490086 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Colonic Diseases; Personal Satisfaction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavior

Study Officials

• Marco Antonio Alvarez González, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

ES (2)