Skip to content

Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03109951
Enrollment
187
Registered
2017-04-12
Start date
2017-03-25
Completion date
2019-12-31
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Type 2 Diabetes Mellitus

Keywords

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

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

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.

Interventions

DRUGColonoscopy preparation using polyethylene glycol

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

Sponsors

Catholic Kwandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

Open label

Intervention model description

Single group

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Abnormal Glucose Levels After Colonoscopic Preparation30 minutes before colonoscopyCount of patients with Serum glucose levels \< 70mg/dL or \>250mg/dL

Secondary

MeasureTime frameDescription
Cognition of Hypoglycemic Symptoms30 minutes before colonoscopySubjects 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 SymptomsFrom colonoscopy preparation beginning to day 1 after colonoscopyDiscover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms

Countries

South Korea

Participant flow

Pre-assignment details

None noted as this was a single-arm study.

Participants by arm

ArmCount
Diabetes Group
Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Colonoscopy preparation using polyethylene glycol: Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
187
Total187

Baseline characteristics

CharacteristicDiabetes Group
Age, Continuous59.5 years
STANDARD_DEVIATION 9.7
Diabetes history7.3 years
STANDARD_DEVIATION 7.9
Fasting glucose level135.9 mg/dL
STANDARD_DEVIATION 33.1
Fasting period19.2 hours
STANDARD_DEVIATION 4.4
Number of adenomas1.1 adenomas
STANDARD_DEVIATION 1.8
Number of advanced adenomas0.2 advanced adenomas
STANDARD_DEVIATION 0.5
Number of polyps1.3 polyps
STANDARD_DEVIATION 2
Race/Ethnicity, Customized
Korean Ethnicity
187 Participants
Region of Enrollment
South Korea
187 participants
Sex: Female, Male
Female
70 Participants
Sex: Female, Male
Male
117 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 187
other
Total, other adverse events
0 / 187
serious
Total, serious adverse events
0 / 187

Outcome results

Primary

Abnormal Glucose Levels After Colonoscopic Preparation

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

Time frame: 30 minutes before colonoscopy

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Diabetes GroupAbnormal Glucose Levels After Colonoscopic PreparationNumber of hyperglycemia subjects2 Participants
Diabetes GroupAbnormal Glucose Levels After Colonoscopic PreparationNumber of hypoglycemia subjects0 Participants
Diabetes GroupAbnormal Glucose Levels After Colonoscopic PreparationNumber of subjects without hypo or hyperglycemia185 Participants
Secondary

Cognition of Hypoglycemic Symptoms

Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them.

Time frame: 30 minutes before colonoscopy

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Diabetes GroupCognition of Hypoglycemic Symptoms96 Participants
Secondary

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

Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms

Time frame: From colonoscopy preparation beginning to day 1 after colonoscopy

Population: 4 subjects reported hypoglycemia symptoms. All recovered through self-treatment (e.g. drinking juice or taking candy).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Diabetes GroupNumber of Participants With Self-treatment and Relief of Hypoglycemic Symptoms4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026