UMIN-CTR Clinical Trial

Public title

Clinical relevance of microalbuminuria and intra-renal RAS in metabolic sydrome patients.
- Effect of olmesartan on microalbuminuria and intrarenal RAS -

Acronym

A multicenter study on the effect of olmesartan on intrarenal RAS in metabolic syndrome patients.

Scientific Title

Clinical relevance of microalbuminuria and intra-renal RAS in metabolic sydrome patients.
- Effect of olmesartan on microalbuminuria and intrarenal RAS -

Scientific Title:Acronym

A multicenter study on the effect of olmesartan on intrarenal RAS in metabolic syndrome patients.

Region

Japan

Condition

Metabolic syndrome with hypertension

Classification by specialty

Cardiology	Endocrinology and Metabolism	Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To elucidate the relevance of microalbuminuria and urinary AGT in metabolic syndrome patients
To evaluate the effect of olmesartan on urinary AGT in metabolic syndrome patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

1) AGT (urine and serum): 0, 12 and 24 weeks after treatment with olmesartan
2) albumin (urine): 0, 12 and 24 weeks after treatment with olmesartan

Key secondary outcomes

1) BP: 0, 4, 8, 12, 16, 20 and 24 weeks after treatment with olmesartan
2) BW, BMI: 0, 12 and 24 weeks after treatment with olmesartan
3) waist circumference: 0, 12 and 24 weeks after treatment with olmesartan
4) FBS, insulin, HbA1c: 0, 12 and 24 weeks after treatment with olmesartan
5) PRA, Aldosterone: 0, 12 and 24 weeks after treatment with olmesartan
6) LDL-chol, HDL-chol, TG: 0, 12 and 24 weeks after treatment with olmesartan
7) gamma-GTP, ALT, AST: 0, 12 and 24 weeks after treatment with olmesartan
8) hsCRP, urinary L-FABP, urinary 8-OHdG, urinary TBARS: 0, 12 and 24 weeks after treatment with olmesartan
9) Cardiovascular events: 0-24 weeks after treatment with olmesartan

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Olmesartan (5-20mg/day, 24 weeks)

Interventions/Control_2

Anti-hypertensive drugs except ARB, ACEI or diuretics (24 weeks)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1) BMI >=25, or waist circumference >= 85 cm (Male), >= 90 cm (Female)
2) SBP >= 130 mmHg or DBP >= 85 mmHg
In addition to above criteria, at least one criterion (below) is needed
1) TG >= 150 mg/dL and/or HDL <= 40 mg/dL
2) FBS >= 110 mg/dL

Key exclusion criteria

1) Pregnancy
2) Patient who has been treated with ARB, ACEI or diuretics within 4 weeks
3) Patient with diabetes mellitus who treats with anti-diabetic drugs
4) Severe hypertension (SBP >= 160 mmHg or DBP >= 110 mmHg)
5) Secondary hypertension
6) Severe renal disease (UACR>300 mg/g, CCr<30 mL/min, sCr >= 2.0 mg/dL)
7) Severe hepatic disease (GOT >= 150 IU or GPT >= 150 IU)
8) History of major cardiac or cerebrovascular events
9) Endocrine disease
10) Patients with malignant tumor
11) Patients inadequate for the study

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Hideyasu Kiyomoto

Organization

Kagawa University, Faculty of Medicine

Division name

Department of Cardiorenal and Cerebrovascular Medicine

Zip code

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL

087-891-5111

Email

Name of contact person

1st name
Middle name
Last name	Hirofumi Hitomi

Organization

Kagawa University, Faculty of Medicine

Division name

Department of Cardiorenal and Cerebrovascular Medicine

Zip code

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL

087-891-5111

Homepage URL

Email

hitomi@kms.ac.jp

Institute

Kagawa University, Faculty of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

02

Month

13

Day

URL releasing protocol

http://www.mdpi.com/1422-0067/17/11/1800/

Publication of results

Published

URL related to results and publications

http://www.mdpi.com/1422-0067/17/11/1800/

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

11

Month

29

Day

Date of IRB

Anticipated trial start date

2008

Year

01

Month

01

Day

Last follow-up date

2011

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

02

Month

13

Day

Last modified on

2016

Year

10

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001241