UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002641 |
|---|---|
| Receipt number | 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 14:00:19 |
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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
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
t.niiya@matsuyama-shimin-hsp.or.jp
Sponsor or person
Institute
MATSUYAMA SHIMIN HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003219
