UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046756 |
|---|---|
| Receipt number | R000053295 |
| Scientific Title | To investigate how to inject insulin in eating pizza among insulin dependent diabetic patients |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/01/31 10:17:53 |
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Basic information
Public title
To investigate how to inject insulin in eating pizza among insulin dependent diabetic patients
Acronym
To investigate how to inject insulin in eating pizza among insulin dependent diabetic patients
Scientific Title
To investigate how to inject insulin in eating pizza among insulin dependent diabetic patients
Scientific Title:Acronym
To investigate how to inject insulin in eating pizza among insulin dependent diabetic patients
Region
| Japan |
Condition
Condition
Insulin dependent diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how to optimize insulin therapy in eating pizza, among insulin dependent diabetic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose levels will be measured at 0, 60, 120, 240, 360minutes after eating pizza at lunch. A-insulin therapy or B-insulin therapy will be undergone before eating pizza. The area under the curve ; blood glucose levels*time(minute) will be compared between the two groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
As A-insulin therapy, insulin aspart (68.7*ICR/10 units) will be undergone in eating pizza which contains 68.7g carbohydrate, 26.0g fat and 24.0g proteins. ICR means insulin carbohydrate ratio.
Interventions/Control_2
As B-insulin therapy, insulin aspart (68.7*ICR/10 units) and intermediate insulin (3FPU*ICR units) will be undergone in eating pizza which contains 68.7g carbohydrate, 26.0g fat and 24.0g proteins. ICR means insulin carbohydrate ratio. 1 FPU (fat-protein unit) is defined as 100 kcal of fat and proteins.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Insulin dependent diabetic inpatients
2.Insulin dependent state is defined as fasting C-peptide immunoreactivity(CPR, ng/mL)/fasting blood glucose levels(mg/dL) < 0.6 as well as delta CPR on the glucagon stimulation test < 1.5.
3.Written informed consent can be obtained
Key exclusion criteria
1.Steroids users
2.pregnant or breastfeeding patients
3.Patients suffering from malignancy within five years
4.Inadequate patients whom researchers judged
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
248-0012
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa, Japan
TEL
045-832-1111
ksqdd034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
248-0012
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa, Japan
TEL
045-832-1111
Homepage URL
ksqdd034@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
no funding
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
Saiseikai Yokohamashi Nanbu Hospital
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa, Japan
Tel
0458321111
soumu01@nanbu.saiseikai.or.jp
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
| 2022 | Year | 02 | Month | 01 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Patients are recruiting.
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All participants will be divided into two groups via miniaturization method using ages and BMI. Participants will take A-insulin therapy on day X and B-insulin therapy on day X+1. Other participants will take B-insulin therapy on day X and A-insulin therapy on day X+1.
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053295
