UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of beneficial effects on left ventricular hypertrophy and diastolic function by metformin in hypertensive patients with type2 DM
Title of the study (Brief title)	Assessment of beneficial effects on left ventricular hypertrophy and diastolic function by metformin
Region	Japan

Condition
Condition	Hypertension, Type 2 diabetes mellitus
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess beneficial effects on left ventricular hypertrophy and diastolic function by metformin in hypertensive patients with type 2 diabetes mellitus using left ventricular mass index of echocardiography and blood biomarkers of heart failure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	1) Left ventricular mass and diastolic function by echocardiography (LVMI, E/A, DT, E/e') 2) Blood biomarker of heart failure (BNP, NT-proBNP)
Key secondary outcomes	1) Left ventricular mass by cardiac MRI 2) Electrocardiogram (assessment of autonomic function by R-R variation) 3) Exploratory analysis To search a patient group in which metformin is useful by carrying out a stratified analysis of patient background male/female, extent and duration of diabetes mellitus, BMI, etc)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral diabetic agents except metformin, and pioglitazone
Interventions/Control_2	Metgluco (drug code) 500-1, 500mg/day p.o.
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	30 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) 30=<age<75 years old (male and female) 2) Patients with hypertension (blood pressure is less than 140/90mmHg and stable for at least 1 month. The subjects include patients who receive antihypertensive medication. LVEF>=50%) 3) Type 2 diabetes mellitus patients with HbA1c>=6.5%. These exclude patients who receive medication with metformin and pioglitazone for 3 months before enrollment. These also exclude patients who receive insulin therapy for 1 year before enrollment. 4) Patients without renal dysfunction (Serum creatinine: <1.3mg/dL (male), <1.2 mg/dL (female)) 5) Patients with informed consent of taking part in clinical research
Key exclusion criteria	1) Patients with type 1 and 2 diabetes mellitus under insulin treatment or secondary diabetes patients 2) Patients with serious hepatic dysfunction/hepatic cirrhosis 3) Patients with unstable angina, acute myocardial infarction, severe coronary artery disease patients (Left Main Trunk or triple-vessel disease) 4) Patients with chronic atrial fibrillation or pacemaker patients 5) Patients with past lactic acidosis 6) Patients with severe dysfunction in cardiovascular system, pulmonary function disabled shock (such as heart failure, myocardial infarction, pulmonary embolism) and with easy to develop other hypoxemia 7) Heavy drinker 8) Patients with gastrointestinal disorder such as diarrhea and vomiting that worried dehydration 9) Patients with severe ketosis, diabetic coma orprecoma patients 10) Patients with severe infection, perioperative, severe injury 11) Those with malnutrition, starvation, debilitation, pituitary insufficiency or adrenal insufficiency patients 12) Those with allergic response for the object medicine 13) Pregnant and lactating patients or the patient who wishes to become pregnant 14) Those who judged inappropriate for the clinical trial
Target sample size	440

Research contact person
Name of lead principal investigator	Koh Ono
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Translational Research
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL	075-641-9161
Email	kohono@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Koji Hasegawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Translational Research
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL	075-641-9161
Homepage URL
Email	koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	National Hospital Organization Kyoto Medical Center

Other related organizations
Co-sponsor	Graduate School of Medicine, Kyoto University
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

北海道がんセンター（北海道）、北海道医療センター（北海道）、函館病院（北海道）、八戸病院（青森県）、岩手病院（岩手県）、栃木病院（栃木県）、宇都宮病院（栃木県）、高崎総合医療センター（群馬県）、西群馬病院（群馬県）、埼玉病院（埼玉県）、東京医療センター（東京都）、横浜医療センター（神奈川県）、金沢医療センター（石川県）、鈴鹿病院（三重県）、滋賀病院（滋賀県）、京都医療センター（京都府）、大阪医療センター（大阪府）、神戸医療センター（兵庫県）、姫路医療センター（兵庫県）、兵庫中央病院（兵庫県）、南和歌山医療センター（和歌山県）、浜田医療センター（島根県）、岡山医療センター（岡山県）、呉医療センター（広島県）、東広島医療センター（広島県）、東徳島医療センター（徳島県）、高松医療センター（香川県）、愛媛病院（愛媛県）、九州医療センター（福岡県）、大牟田病院（福岡県）、嬉野医療センター（佐賀県）、長崎川棚医療センター（長崎県）、熊本医療センター（熊本県）、大分医療センター（大分県）、宮崎東病院（宮崎県）、鹿児島医療センター（鹿児島県）

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 16 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2015 Year 09 Month 01 Day
Date of closure to data entry	2016 Year 09 Month 01 Day
Date trial data considered complete	2016 Year 09 Month 01 Day
Date analysis concluded

Related information
URL releasing protocol	https://www.nhocrc.jp/ABLEMETpage.html
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 10 Month 07 Day
Last modified on	2018 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007716