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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006606
Receipt No. R000007814
Scientific Title Effect of olmesartan on beta-cell function and diabetic angiopathy in type 2 diabeteic patients with hypertension
Date of disclosure of the study information 2011/10/25
Last modified on 2011/10/25

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Basic information
Public title Effect of olmesartan on beta-cell function and diabetic angiopathy in type 2 diabeteic patients with hypertension
Acronym beta-Function and Atherosclerosis by Olmesartan and Nateglinide
Scientific Title Effect of olmesartan on beta-cell function and diabetic angiopathy in type 2 diabeteic patients with hypertension
Scientific Title:Acronym beta-Function and Atherosclerosis by Olmesartan and Nateglinide
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate whether an ARB olmesartan would improve beta-cell function and prevent diabetic angiopathy in type 2 diabeteic patients with hypertension. We also examine whether treatment with olmesartan would affect the serum levels of the soluble form of RAGE.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoints of the study were
1) Achievement rate of targeted blood pressure (<130/85mmHg) during a 24-week treatment period
2) Improvement rate of fasting blood glucose and HbA1c levels during a 24-week treatment period
Key secondary outcomes The secondary endpoints were
1) Changes in the IMT value (mean and max IMT) during a 24-week treatment period measured by carotid arterial echography
2) Changes in the serum esRAGE levels during a 24-week treatment period
3) Changes in the insulin secretion and insulin resistance during a 24-week treatment period
4) Changes in the urinary albumin excretion rates during a 24-week treatment period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olmesartan treatment group (Group O);
Clinical investigators will initiate olmesartan (20mg/day) treatment following the allocation in the olmesartan treatment group. Treatment will be continued to achieve the target value specified in the hypertension treatment guidelines (<130/85 mmHg).
Interventions/Control_2 Amlodipine treatment group (Group A);
Clinical investigators will initiate amlodipine (5mg/day) treatment following the allocation in the amlodipine treatment group. Treatment will be continued to achieve the target value specified in the hypertension treatment guidelines (<130/85 mmHg).
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 Inclusion criteria
1) Type 2 diabetes patients (HbA1c (JDS value) below 8.0%) treated with dietary/exercise therapy and/or alpha-glucosidase inhibitors or nateglinide.
2) Having hypertension
3) aged 30 to 75 years of age at the time of enrollment (regardless of gender)
4) Written consent for participation in the study
Key exclusion criteria Patients meeting one of the following conditions will be excluded:
1) unable to visit the outpatient clinics of diabetes periodically
2) diabetic retinopathy
3) advanced (&#8805; stage 4) diabetic nephropathy
4) severe hypertension (systolic blood pressure &#8805; 180 mmHg and/or diastolic blood pressure &#8805; 110 mmHg
5) diagnosed as having malignancy within 5 years
6) Judged as ineligible by clinical investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Kaneto
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Metabolic Medicine, Osaka University Graduate School of Medicine
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)

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 松島医院(兵庫県)、児玉内科医院(兵庫県)、大歳内科(大阪府)、白岩医院(大阪府)、西淀病院内科(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 25 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 Enrolling by invitation
Date of protocol fixation
2008 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2012 Year 11 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
2011 Year 10 Month 25 Day
Last modified on
2011 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007814

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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