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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026348
Receipt No. 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 2018/01/22

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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
Middle name
Last name Junji Kozawa
Organization Graduate School of Medicine, Osaka University
Division name Department of Metabolic Medicine
Zip code
Address 2-2-B5,Yamadaoka,Suita city,Osaka
TEL 06-6879-3732
Email kjunji@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Fujita
Organization Graduate School of Medicine, Osaka University
Division name Department of Metabolic Medicine
Zip code
Address 2-2-B5,Yamadaoka,Suita city,Osaka
TEL 06-6879-3732
Homepage URL
Email lutefs222@endmet.med.osaka-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Osaka University
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 31 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
2017 Year 03 Month 01 Day
Last modified on
2018 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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