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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes group | Other | Type 2 diabetes patients undergoing colonoscopy with preparation with 2L of polyethylene glycol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy preparation using polyethylene glycol | Drug | Colonoscopy preparation using standard preparation with 2L of polyethylene glycol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Glucose Levels After Colonoscopic Preparation | Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL | 30 minutes before colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition of Hypoglycemic Symptoms | Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them. | 30 minutes before colonoscopy |
| Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myong Ki Baeg, MD, PhD | International St. Mary's Hospital, Catholic Kwandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International St.Mary's Hospital | Incheon | 22711 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19696663 | Background | 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. | |
| 15185785 | 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. |
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None noted as this was a single-arm study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abnormal Glucose Levels After Colonoscopic Preparation | Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL | Posted | Count of Participants | Participants | 30 minutes before colonoscopy |
|
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Adverse event data were collected for 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Smaller number of subjects than anticipated due to poor enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myong Ki Baeg | International St. Mary's Hospital, Catholic Kwandong University | 82-10-6391-9010 | baegmk@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2018 | Mar 6, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2018 | Mar 6, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single group
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Open label
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Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms |
| From colonoscopy preparation beginning to day 1 after colonoscopy |
| 20889933 | 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. |
| 24557963 | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fasting glucose level | Mean | Standard Deviation | mg/dL |
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| Number of polyps | Mean | Standard Deviation | polyps |
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| Number of adenomas | Mean | Standard Deviation | adenomas |
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| Number of advanced adenomas | Mean | Standard Deviation | advanced adenomas |
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| Diabetes history | Previous Diabetes history before study enrollment. | Mean | Standard Deviation | years |
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| Fasting period | Time(hours) from last meal intake to colonoscopy start. | Mean | Standard Deviation | hours |
|
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| Secondary | Cognition of Hypoglycemic Symptoms | Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them. | Posted | Count of Participants | Participants | 30 minutes before colonoscopy |
|
|
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| Secondary | Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms | Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms | 4 subjects reported hypoglycemia symptoms. All recovered through self-treatment (e.g. drinking juice or taking candy). | Posted | Count of Participants | Participants | From colonoscopy preparation beginning to day 1 after colonoscopy |
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| 0 |
| 187 |
| 0 |
| 187 |
| 0 |
| 187 |
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| D004700 | Endocrine System Diseases |