UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000901
Receipt No. 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 2010/11/22

* 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 Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Acronym Optimal combination of pharmacological agents for diabetic complications
Scientific Title Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Scientific Title:Acronym Optimal combination of pharmacological agents for diabetic complications
Region
Japan

Condition
Condition Cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Prevention against cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance by a combination of statin and angiotensin receptor blocker in Japanese.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Impaired glucose tolerance, Insulin resistance; HOMA-R, Initial renal disease; Urinalysis for protein, Vascular disease; pulse wave velocity (PWV)
Key secondary outcomes 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

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 A water soluble statin (Pravastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.
Interventions/Control_3 A lipid soluble statin (Atorvastatin) for hyperlipidemia and antihypertensive agents except ARBs and ACEIs such as Ca antagonists for hypertension for a year.
Interventions/Control_4 A lipid soluble statin (Atorvastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hasegawa
Organization Kyoto Medical Centar
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL 075-645-8401(-6132)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Wada
Organization Kyoto Medical Centar
Division name Division of Translational Resaerch
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL 075-645-8401(-8809)
Homepage URL
Email hwada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Medical Centar
Institute
Department

Funding Source
Organization Japanese Government
Organization
Division
Category of Funding Organization
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
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2005 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 11 Month 19 Day
Last modified on
2010 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000300

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.