Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

NCT03109951 | Completed Results DMC

• 1 other identifier: IS16OASI0026
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes is rapidly increasing globally and has been associated with an increased risk of colorectal cancer. Therefore, the numbers of diabetic patients who will undergo colonoscopic screening are expected to grow exponentially. Colonoscopic preparation entails prolonged fasting, cessation of anti-diabetic medication and ingestion of preparation medications. This may put the diabetic patient at risk of potentially dangerous hypo- or hyperglycemia. However, studies regarding the safety of colonoscopic preparation in diabetic are lacking. In this study, the investigators aim to discover the prevalence of abnormal glucose levels in diabetic patients who undergo colonoscopy. The investigators also aim to find out risk factors for abnormal glucose levels and develop a safe preparation protocol.

Conditions

Type 2 Diabetes Mellitus; Colonoscopy

Keywords

Type 2 diabetes; colonoscopy; hypoglycemia; hyperglycemia; polyethylene glycol

Outcome Measures

Primary Outcomes (1)

• Abnormal Glucose Levels After Colonoscopic Preparation

  Count of patients with Serum glucose levels \< 70mg/dL or \>250mg/dL

  30 minutes before colonoscopy

Secondary Outcomes (2)

• Cognition of Hypoglycemic Symptoms

  30 minutes before colonoscopy

• Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms

  From colonoscopy preparation beginning to day 1 after colonoscopy

Study Arms (1)

Diabetes group

OTHER

Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.

Drug: Colonoscopy preparation using polyethylene glycol

Interventions

Colonoscopy preparation using polyethylene glycol DRUG

Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.

Also known as: Have not taken diabetes medication since 6pm of the day before colonoscopy., Have fasted since 6pm of the day before colonoscopy.

Diabetes group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Between ages of 20-75
• Undergo colonoscopy at International St. Mary's Hospital

You may not qualify if:

• Type 1 diabetes patients
• Did not undergo colonoscopy preparation
• Did not meet fasting requirements
• Have known current infectious diseases
• Have known cancer and/or are under cancer treatment
• Are under intravenous fluid therapy during colonoscopy

Sponsors & Collaborators

• Catholic Kwandong University: lead

Study Sites (1)

International St.Mary's Hospital

Incheon, 22711, South Korea

Location

Related Publications (4)

• Vann MA. Perioperative management of ambulatory surgical patients with diabetes mellitus. Curr Opin Anaesthesiol. 2009 Dec;22(6):718-24. doi: 10.1097/ACO.0b013e3283310f51.

  PMID: 19696663 BACKGROUND

• Kollarits CR, Kendrick RM, Guess M. Perioperative treatment of patients with diabetes having eye surgery with local anesthesia in an ambulatory facility. Ophthalmic Surg Lasers Imaging. 2004 May-Jun;35(3):185-8.

  PMID: 15185785 BACKGROUND

• Joshi GP, Chung F, Vann MA, Ahmad S, Gan TJ, Goulson DT, Merrill DG, Twersky R; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia consensus statement on perioperative blood glucose management in diabetic patients undergoing ambulatory surgery. Anesth Analg. 2010 Dec;111(6):1378-87. doi: 10.1213/ANE.0b013e3181f9c288. Epub 2010 Oct 1.

  PMID: 20889933 BACKGROUND

• Yao J, Zhang W, Chen J, Zhang G, Zheng S. Enteral nutrition before bowel preparation improves the safety of colonoscopy in the elderly. Turk J Gastroenterol. 2013;24(5):400-5. doi: 10.4318/tjg.2013.0638.

  PMID: 24557963 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Smaller number of subjects than anticipated due to poor enrollment.

Results Point of Contact

• Title: Myong Ki Baeg
• Organization: International St. Mary's Hospital, Catholic Kwandong University

baegmk@gmail.com

82-10-6391-9010

Study Officials

• Myong Ki Baeg, MD, PhD

  International St. Mary's Hospital, Catholic Kwandong University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Single group

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 12, 2017
• Study Start: March 25, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)