Unique ID issued by UMIN | UMIN000000901 |
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Receipt number | R000000300 |
Scientific Title | Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance |
Date of disclosure of the study information | 2009/04/01 |
Last modified on | 2020/10/19 09:30:51 |
Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Optimal combination of pharmacological agents for diabetic complications
Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Optimal combination of pharmacological agents for diabetic complications
Japan |
Cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Cardiology | Endocrinology and Metabolism | Nephrology |
Others
NO
Prevention against cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance by a combination of statin and angiotensin receptor blocker in Japanese.
Efficacy
Exploratory
Pragmatic
Not applicable
Impaired glucose tolerance, Insulin resistance; HOMA-R, Initial renal disease; Urinalysis for protein, Vascular disease; pulse wave velocity (PWV)
Blood pressure at rest, Pulse rate, Total cholesterol, Triglyceride, HDL cholesterol, Fasting plasma glucose (FPG), Hemoglobin A1c (HbA1c), Fasting serum insulin, Height, Weight, Body mass index(BMI), Echocardiography (IVSt, PWt, LVEDd, LVESd, Diastolic function; E/A ratio, Deceleration time), Electrocardiography at rest, Serum Creatinine, Urinalysis, Urine Creatinine, Urine Albumin, Intima-media thickness and plaque by carotid echography, Ankle-Brachial index(ABI), Total death count, Incidence of cardiovascular event, Incidence of discontinuance, Incidence of advers event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
4
Prevention
Medicine |
A water soluble statin (Pravastatin) for hyperlipidemia and antihypertensive agents except angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs) such as Calcium (Ca) antagonists for hypertension for a year.
A water soluble statin (Pravastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.
A lipid soluble statin (Atorvastatin) for hyperlipidemia and antihypertensive agents except ARBs and ACEIs such as Ca antagonists for hypertension for a year.
A lipid soluble statin (Atorvastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.
30 | years-old | <= |
80 | years-old | > |
Male and Female
Positive findings from all of the following tests:
1) Positive findings from one of a)-d)
a) Impaired glucose tolerance; FPG from 110 to <126 mg/dl or 2hrPPG from 140 to <200 mg/dlorb)
b) HOMR-R(=FPG x Insulin level/405) >=1.73
c) HbA1c> 5.6
d) already taking any oral hypoglycemic drugs
2) B.P. at sitting position >=130/80 mmHg
3) LDL cholesterol level >=120 mg/dl
4) At least 3 months after the first instruction of diet therapy by a specialist
5) Not taking either statins or angiotensin receptor blocker for more than 3 momnths
6) Not applying to exceptions as below
1) Receiving insulin therapy
2) Having severe liver dysfunction or cirrhosis
3) Having severe renal dysfunction (Cre>=2.0) or under hemodialysis
4) Cerebrovascular disease within 3 months
5) Unstable angina, acute myocardial infarction, or severe coronary artery disease (left main trunk or 3-vessel disease)
6) Left ventricular dysfunction (LVEF<35%)
7) Not controlled hypertension (systolic BP>=180 mmHg with antihypertensive agents)
8) Not controlled hyperlipidemia (serum LDL level 180>=mmHg with antihyperlipidemic agents)
9) Having malignant tumor
10) Taking a steroid
11) Having allergy against these drugs
12) During pregnancy or the lactation period or having wish for pregnancy within a year
13) Regarded as unsuitable by the doctor in charge
300
1st name | |
Middle name | |
Last name | Koji Hasegawa |
Kyoto Medical Centar
Division of Translational Research
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
075-645-8401(-6132)
1st name | |
Middle name | |
Last name | Hiromichi Wada |
Kyoto Medical Centar
Division of Translational Resaerch
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
075-645-8401(-8809)
hwada@kuhp.kyoto-u.ac.jp
Kyoto Medical Centar
Japanese Government
NO
2009 | Year | 04 | Month | 01 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000300
Published
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266803/
231
LV mass and diastolic function were not affected after 1 year of metformin treatment in patients with T2DM. However, we observed benefits in terms of reductions in both BMI and LDL-C levels and preservation of renal function
2020 | Year | 10 | Month | 19 | Day |
2020 | Year | 06 | Month | 20 | Day |
Patients with T2DM with a history of hypertension
Patient Subjects were randomized 1:1 to treatment for 1 year with either metformin (metformin-treated group) or other hypoglycemic agents (control group).
Serious adverse events related with this intervention were not observed.
The primary endpoints were changes in brain natriuretic peptide (BNP) levels, left ventricular (LV) mass index, and indicators of LV diastolic function. We also evaluated changes in both clinical findings and blood laboratory examination data.
Completed
2005 | Year | 07 | Month | 15 | Day |
2005 | Year | 10 | Month | 01 | Day |
2009 | Year | 06 | Month | 01 | Day |
2007 | Year | 11 | Month | 19 | Day |
2020 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000300
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