UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012265 |
|---|---|
| Receipt number | R000014341 |
| Scientific Title | Evaluation of safety of insulin degludec on undergoing total-colonoscopy using continuous glucose monitoring |
| Date of disclosure of the study information | 2013/11/11 |
| Last modified on | 2014/03/26 15:55:20 |
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Basic information
Public title
Evaluation of safety of insulin degludec on undergoing total-colonoscopy using continuous glucose monitoring
Acronym
Safety of degludec on undergoing total-colonoscopy using CGM
Scientific Title
Evaluation of safety of insulin degludec on undergoing total-colonoscopy using continuous glucose monitoring
Scientific Title:Acronym
Safety of degludec on undergoing total-colonoscopy using CGM
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
colon cancer
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Screening of colon cancer with total-colonoscopy (TCS) in type 2 diabetic patients is significant clinical approach. Anti-diabetic agent should be reduced or discontinued because preparation for TCS forces the patient to be long fasting. However, there is little information regarding how to adjust insulin degludec (D) having an ultra-long action profile.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoints were to evaluate the frequency of hypoglycemia (below 70 mg/dl), Hypoglycemic Index, mean glucose level (MEAN) and standard deviation (SD) in daytime fasting duration (between 8 am and 6 pm on the day of TCS) (F duration).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
In admission, CGM was attached from the previous day to the following day of TCS. Patients had been fasting for 24 hours after the supper (6 pm) on the previous day. At breakfast and lunch on the day of TCS, patients discontinued all anti-diabetic agents and took polyethylene glycol electrolyte solution.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes mellitus treated with insulin degludec
Key exclusion criteria
1) severe renal dysfunction (serum creatinine level over 2.0 mg/dL)
2) judged to be unsuitable for participation for medical reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeisi Soichi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1-Kaimei hira-Ichinomiya city-Aichi
TEL
0586-48-0077
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeisi Soichi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1-Kaimei hira-Ichinomiya city-Aichi
TEL
0586-48-0077
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Ichinomiyanishi Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 11 | Day |
Last modified on
| 2014 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014341
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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