Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

NCT ID: NCT03109951

Last Updated: 2020-03-20

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-25

Study Completion Date

2019-12-31

Brief Summary

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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

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1. Type 2 diabetes subjects who will undergo colonoscopy will be prospectively enrolled when visiting the outpatient clinic.
2. Subjects will be instructed to fast from 6pm of the day before colonoscopy.
3. Subjects will be instructed to abstain from diabetes medication while the subjects fast.
4. 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.
5. Subjects will be instructed to take the preparation medication at rate of 250 mL every 10 to 15 minutes.
6. 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.
7. Subjects will have vital signs (blood pressure, heart rate) taken and their capillary glucose levels checked using the Accu-Chek Performa.
8. 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.
9. 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.

Conditions

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Type 2 Diabetes Mellitus Colonoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open label

Study Groups

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Diabetes group

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

Group Type OTHER

Colonoscopy preparation using polyethylene glycol

Intervention Type DRUG

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

Interventions

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Colonoscopy preparation using polyethylene glycol

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

Intervention Type DRUG

Other Intervention Names

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Have not taken diabetes medication since 6pm of the day before colonoscopy. Have fasted since 6pm of the day before colonoscopy.

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic Kwandong University

OTHER

Sponsor Role lead

Responsible Party

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Myong Ki Baeg

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myong Ki Baeg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

International St. Mary's Hospital, Catholic Kwandong University

Locations

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International St.Mary's Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 19696663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15185785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20889933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24557963 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IS16OASI0026

Identifier Type: -

Identifier Source: org_study_id

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