UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002641
Receipt No. R000003219
Scientific Title A open label, randomized, controled trial to assess the usefulness of telmisartan in patients with type 2 diabetes, obesity, and NAFLD.
Date of disclosure of the study information 2009/10/21
Last modified on 2009/10/22

* 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 A open label, randomized, controled trial to assess the usefulness of telmisartan in patients with type 2 diabetes, obesity, and NAFLD.
Acronym Matsuyama Shimin Hospital, Hypertension therapy for patients with type2 diabetes, obesity and NAFLD. (MADONNA study)
Scientific Title A open label, randomized, controled trial to assess the usefulness of telmisartan in patients with type 2 diabetes, obesity, and NAFLD.
Scientific Title:Acronym Matsuyama Shimin Hospital, Hypertension therapy for patients with type2 diabetes, obesity and NAFLD. (MADONNA study)
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine whether telmisartan, an angiotensin receptor blocker with partial peroxisome proliferators-activated receptor gamma agonist activity, may improve metabolic disorders in type 2 diabetes patients with obesity and NAFLD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Content of visceral fat and fatty liver
Key secondary outcomes HbA1c, fasting glucose, fasting CPR, ABI/PWV, body weight, blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
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 (Telmisartan group)
Patients under treatment with telmisartan (40mg/day) are switched from valsartan (80mg/day) to telmisartan at the dose of 40mg/day for 6months.
Interventions/Control_2 (Valsartan group)
Patients under treatment with valsartan (80mg/day) group will continue therapy with valsartan at the dose of 80 mg/day for 6 months.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who have been under treatment with valsartan for hypertension for more than 3 months.
2) Patients with more than 100cm2 of visceral fat.
3) Patients with an HbA1c level under 8%.
Key exclusion criteria 1) Patients whose fatty liver is difficult to evaluate. (A heavy drinker, other liver diseases, etc.)
2) Patients requiring hospitalization to attain glycemic control.
3) Patients judged inadequate to participate in this study by their physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TETSUJI NIIYA
Organization MATSUYAMA SHIMIN HOSPITAL
Division name Internal medicine
Zip code
Address Ohtemachi 2-6-5, Matsuyama city, Ehime prefecture
TEL 089-943-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name TETSUJI NIIYA
Organization MATSUYAMA SHIMIN HOSPITAL
Division name Internal medicine
Zip code
Address Ohtemachi 2-6-5, Matsuyama city, Ehime prefecture
TEL 089-943-1151
Homepage URL
Email t.niiya@matsuyama-shimin-hsp.or.jp

Sponsor
Institute MATSUYAMA SHIMIN HOSPITAL
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 愛媛大学医学部第3内科関連施設(愛媛県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 21 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 19 Day
Last modified on
2009 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003219

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.