UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019126 |
|---|---|
| Receipt number | R000022097 |
| Scientific Title | Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2018/10/02 02:29:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes
Acronym
Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes
Scientific Title
Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes
Scientific Title:Acronym
Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reality of metformin-induced vitamin B12 deficiency in patients with type 2 diabetes by measuring the serum vitamin B12 and homocysteine level as the diagnostic index. To investigate the relationship of the dose of metformin and vitamin B12 deficiency.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The corelation between the period of taking metformin and serum homocysteine or vitamin B12 level as the diagnostic index for vitamin B12 deficiency.
Key secondary outcomes
1)The corelation between the daily dose of metformin and serum homocysteine or vitamin B12 level as the diagnostic index for vitamin B12 deficiency.
2)The corelation between the cumulative dose of metformin and serum homocysteine or vitamin B12 level.
3)The relationship between macrocytic anemia and serum homocysteine or vitamin B12 level.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 2 diabetes
2)type 2 patients who taking metformin within the conditions specified in the product labeling
Key exclusion criteria
1)Is receiving vitamin B12 preparation including vitamin B12 supplements
2)Is receiving steroids, and gastrectomy (include segmentectomy and total resection, but not endoscopic mucosal resection)
3)Is pregnant, nursing, or planned to become pregnant
4)With malabsorption(chronic pancreatitis,inflammatory bowel disease and malabsorption syndrome)
5)With severe infection, pre or post surgery, and serious trauma,malignancy
6)With renal dysfunction (Serum Creatinine male: >= 1.5 mg/dL, female: >= 1.3 mg/dL)
7)Considered as inadequate by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology
Zip code
Address
7-5-1 Kusunokichou, Chuo-ku, Kobe, Japan
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Okada |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology
Zip code
Address
7-5-1 Kusunokichou, Chuo-ku, Kobe, Japan
TEL
078-382-5861
Homepage URL
yokada@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
none
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
神戸大学大学院医学研究科 糖尿病・内分泌内科(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
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
| 2015 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study.
Patients who visit our hospital from February 2016 to December 2020 and those who meeting the criteria.
Management information
Registered date
| 2015 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022097
