Type 2 Diabetes MellitusNCT03109951

Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation

A study testing Colonoscopy preparation using polyethylene glycol in people with Type 2 Diabetes Mellitus and Colonoscopy, run by Catholic Kwandong University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus, Colonoscopy
What is being tested?: Colonoscopy preparation using polyethylene glycol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 187 participants
Where: 1 siteSouth Korea
Study dates: 25 Mar 2017to 31 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

International St.Mary's Hospital
Incheon, 22711

Other trials in South Korea

About this study

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.

Read the 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.

Conditions: Type 2 Diabetes Mellitus, Colonoscopy
Being tested: Colonoscopy preparation using polyethylene glycol
Keywords: Type 2 diabetes, colonoscopy, hypoglycemia, hyperglycemia, polyethylene glycol
Medical subject headings: Diabetes Mellitus, Type 2, Hypoglycemia, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colonoscopy preparation using polyethylene glycolDrug
Also called Have not taken diabetes medication since 6pm of the day before colonoscopy., Have fasted since 6pm of the day before colonoscopy.
Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.

Study groups in NCT03109951
Study group	Role	What they receive
Diabetes group	Other	Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. Receives: Drug: Colonoscopy preparation using polyethylene glycol

What is being measured

The primary outcome is the main question the study is designed to answer.

Abnormal Glucose Levels After Colonoscopic Preparation
Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL
Measured: 30 minutes before colonoscopy

Secondary outcomes (2)

Cognition of Hypoglycemic Symptoms
Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them.
Measured: 30 minutes before colonoscopy
Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms
Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms
Measured: From colonoscopy preparation beginning to day 1 after colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 201731 Dec 2019

First posted12 Apr 2017
Study start25 Mar 2017
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Single group
Masking: None (open label)
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03109951
Sponsor's protocol ID: IS16OASI0026
Status last verified: Mar 2020
First submitted: 3 Apr 2017
Last updated: 20 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19696663
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.
PubMed 15185785
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.
PubMed 20889933
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.
PubMed 24557963

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Abnormal Blood Sugar Tests in Diabetic Patients During Colonoscopy Preparation
ClinicalTrials.gov ID: NCT03109951
Acronym / sponsor ID: IS16OASI0026
Conditions: Type 2 Diabetes Mellitus, Colonoscopy
Keywords: Type 2 diabetes, colonoscopy, hypoglycemia, hyperglycemia, polyethylene glycol
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Catholic Kwandong UniversityUniversity, hospital or other
Study start: 25 Mar 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 12 Apr 2017 (actual)
Results: Posted 20 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single group

Arm	Type	Receives
Diabetes group	Other	Drug: Colonoscopy preparation using polyethylene glycolType 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colonoscopy preparation using polyethylene glycolAlso: Have not taken diabetes medication since 6pm of the day before colonoscopy., Have fasted since 6pm of the day before colonoscopy.Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.	Drug	Diabetes group

Primary outcome

Abnormal Glucose Levels After Colonoscopic Preparation
Time frame: 30 minutes before colonoscopy
Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL

2 secondary outcomes

Cognition of Hypoglycemic Symptoms
Time frame: 30 minutes before colonoscopy
Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms
Time frame: From colonoscopy preparation beginning to day 1 after colonoscopy

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetes Group	187	187

Primary outcome: Abnormal Glucose Levels After Colonoscopic Preparation

Time frame: 30 minutes before colonoscopy. Count of participants. Unit: Participants

Measure	Diabetes Group n = 187
Number of hyperglycemia subjects	2
Number of hypoglycemia subjects	0
Number of subjects without hypo or hyperglycemia	185

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 1 month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetes Group	0 of 187 (0%)	0 of 187 (0%)	0 of 187

Limitations and caveats (from the sponsor): Smaller number of subjects than anticipated due to poor enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19696663Vann MA. Perioperative management of ambulatory surgical patients with diabetes mellitus. Curr Opin Anaesthesiol. 2009 Dec;22(6):718-24. doi: 10.1097/ACO.0b013e3283310f51.
Background: PubMed 15185785Kollarits 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.
Background: PubMed 20889933Joshi 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.
Background: PubMed 24557963Yao 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.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Myong Ki Baeg, MD, PhD principal investigator

International St. Mary's Hospital, Catholic Kwandong University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Colonoscopy preparation using polyethylene glycol in people with Type 2 Diabetes Mellitus and Colonoscopy, run by Catholic Kwandong University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abnormal Glucose Levels After Colonoscopic Preparation (time frame: 30 minutes before colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109951, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.