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Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

Primary Purpose

Type 2 Diabetes Mellitus, Colonoscopy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Colonoscopy preparation using polyethylene glycol
Sponsored by
Catholic Kwandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, colonoscopy, hypoglycemia, hyperglycemia, polyethylene glycol

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • International St.Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diabetes group

Arm Description

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

Outcomes

Primary Outcome Measures

Abnormal Glucose Levels After Colonoscopic Preparation
Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL

Secondary Outcome Measures

Cognition of Hypoglycemic Symptoms
Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them.
Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms
Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms

Full Information

First Posted
April 3, 2017
Last Updated
March 6, 2020
Sponsor
Catholic Kwandong University
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1. Study Identification

Unique Protocol Identification Number
NCT03109951
Brief Title
Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation
Official Title
Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic Kwandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Type 2 diabetes subjects who will undergo colonoscopy will be prospectively enrolled when visiting the outpatient clinic. Subjects will be instructed to fast from 6pm of the day before colonoscopy. Subjects will be instructed to abstain from diabetes medication while the subjects fast. Subjects who are scheduled to undergo colonoscopy in the morning will take colonoscopy preparation medication (2L (liter) of polyethylene glycol with ascorbic acid) in a split dose (i.e. 1L from 8-10 pm of the day before colonoscopy and 1L 4-6 hours before colonoscopy). Those who will undergo colonoscopy in the afternoon will take 2L of the preparation medication 6 hours before colonoscopy. Subjects will be instructed to take the preparation medication at rate of 250 mL every 10 to 15 minutes. Upon arrival at the endoscopy center of International St. Mary's hospital, subjects will be given a self-administered questionnaire which will ask about their age, gender, duration of diabetes, type of diabetes medication, time of last diabetes medication taken, knowledge of hypo/hyperglycemia symptoms, previous hypo/hyperglycemia experience, self-treatment of hypoglycemia (if done), total amount of colonoscopy preparation medication ingested, total fasting time and time of last preparation medication ingested. Subjects will have vital signs (blood pressure, heart rate) taken and their capillary glucose levels checked using the Accu-Chek Performa. Any subjects with capillary glucose levels <70mg/dL or >250mg/dL will be reported to the attending physician. Those with an initial glucose level <70mg/dL will be given a piece of candy and have their glucose rechecked in 10 mins. Subjects will be asked if the hypoglycemic symptoms (if any) have abated. Those with a glucose level >250mg/dL will undergo hydration with normal saline at 120 ml/Hr. Those who do not respond to treatment or are in critical condition will be moved to the Emergency department for treatment. Subjects who respond to treatment will have their glucose levels checked after colonoscopy before undergoing discharge. Those with abnormal levels upon follow-up testing will be sent to either the endocrinology outpatient clinic or the emergency room depending on their clinical severity. All data will be recorded by initials with patient identities masked. All data will be kept in a locked and secure location by the principal investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Colonoscopy
Keywords
Type 2 diabetes, colonoscopy, hypoglycemia, hyperglycemia, polyethylene glycol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes group
Arm Type
Other
Arm Description
Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.
Intervention Type
Drug
Intervention Name(s)
Colonoscopy preparation using polyethylene glycol
Other Intervention Name(s)
Have not taken diabetes medication since 6pm of the day before colonoscopy., Have fasted since 6pm of the day before colonoscopy.
Intervention Description
Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
Primary Outcome Measure Information:
Title
Abnormal Glucose Levels After Colonoscopic Preparation
Description
Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL
Time Frame
30 minutes before colonoscopy
Secondary Outcome Measure Information:
Title
Cognition of Hypoglycemic Symptoms
Description
Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them.
Time Frame
30 minutes before colonoscopy
Title
Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms
Description
Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms
Time Frame
From colonoscopy preparation beginning to day 1 after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Between ages of 20-75 Undergo colonoscopy at International St. Mary's Hospital Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myong Ki Baeg, MD, PhD
Organizational Affiliation
International St. Mary's Hospital, Catholic Kwandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International St.Mary's Hospital
City
Incheon
ZIP/Postal Code
22711
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19696663
Citation
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.
Results Reference
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PubMed Identifier
15185785
Citation
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.
Results Reference
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PubMed Identifier
20889933
Citation
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.
Results Reference
background
PubMed Identifier
24557963
Citation
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.
Results Reference
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Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

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