UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026348 |
|---|---|
| Receipt number | R000030190 |
| Scientific Title | Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia. |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2019/09/02 18:53:54 |
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Basic information
Public title
Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Acronym
Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Scientific Title
Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Scientific Title:Acronym
Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of high-dose vitamin B12 treatment in type 1 diabetic patient with impaired awareness of hypoglycemia accompanied with autonomic dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms of hypoglycemia in an insulin tolerance test(Day 21~28)).
Key secondary outcomes
Autonomic function(coefficient of variation of R-R interval, Schellong test)
Epinephrine, norepinephrine, dopamine, cortisol, ACTH, growth hormone, glucagon
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vitamin B12 intramuscularly injection 1mg per day for 3 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Type 1 diabetes(Eligible participants had a known history of type 1 diabetes for at least 6 months, and had been treated for at least 6 months with a basal-bolus insulin regimen)
2)Treatment with multiple insulin injection
3)Hypoglycemia unawareness
4)Autonomic dysfunction
Key exclusion criteria
1)Patients younger than 19 years old.
2)Severe liver dysfunction
3)Severe renal failure
4)Pregnant
5)Angina pectoris,epilepsy,preproliferative diabetic retinopathy(PPDR) and proliferative diabetic retinopathy(PDR)
6)Judged as ineligible by clinical investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Kozawa |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
5650871
Address
2-2-B5,Yamadaoka,Suita city,Osaka
TEL
06-6879-3732
kjunji@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Fujita |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2-B5,Yamadaoka,Suita city,Osaka
TEL
06-6879-3732
Homepage URL
lutefs222@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Osaka University
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
Graduate School of Medicine, Osaka University
Address
B5, 2, 2-1-1 Yamadaoka Suita
Tel
06-6879-5111
lutefs222@endmet.med.osaka-u.ac.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
| 2017 | Year | 03 | Month | 31 | 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
1
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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030190
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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