UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes
Title of the study (Brief title)	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	Kazuhiko Sakaguchi
Organization	Kobe University Graduate School of Medicine
Division name	Division of Diabetes and Endocrinology
Address	7-5-1 Kusunokichou, Chuo-ku, Kobe, Japan
TEL	078-382-5861
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	Yuko Okada
Organization	Kobe University Graduate School of Medicine
Division name	Division of Diabetes and Endocrinology
Address	7-5-1 Kusunokichou, Chuo-ku, Kobe, Japan
TEL	078-382-5861
Homepage URL
Email	yokada@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022097