UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000107 |
|---|---|
| Receipt number | R000000155 |
| Scientific Title | DIAbetes and diffuse coronary Narrowing Analysis Study |
| Date of disclosure of the study information | 2005/09/01 |
| Last modified on | 2009/05/13 12:13:37 |
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Basic information
Public title
DIAbetes and diffuse coronary Narrowing Analysis Study
Acronym
DIANA study
Scientific Title
DIAbetes and diffuse coronary Narrowing Analysis Study
Scientific Title:Acronym
DIANA study
Region
| Japan |
Condition
Condition
Patients with impaired fasting glucose or type-2 diabetes mellitus, who had coronary artery diseases
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether strict glycemic control specifically targeting postprandial hyperglycemia may prevent the development of coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lesion length, vessel diameter, percentage diameter stenosis
Key secondary outcomes
MACE (all-cause death, non-fatal myocardial infarction, repeat revascularization, the occurrence of anginal chest pain), diabetic complication, the change of % diameter stenosis after PCI, the change of minimum lesional diameter after PCI, the occurrence of restenosis, the development of new stenotic lesion, the change of glycemic status
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients treated with voglibose (n=100)
Interventions/Control_2
Patients treated with nateglinide (n=100)
Interventions/Control_3
patients treated without medication, with diet and exercise (n=100)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients who had organic stenosis in coronary angiography
2) patients who were diagnosed as impaired glucose tolerance or diabetes mellitus by a 75g-OGTT
Key exclusion criteria
1) patinets with acute myocardial infarction within 48 hrs
2) patients who previously underwent coronary artery bypass surgery
3) patients who were being treated by anti-diabetic medication
4) patients who had allergic reaction to voglibose or nateglinide
5) patients with real insufficiency (serun creatinine more than 2.0mg/dl)
6) patients who were seriously ill
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Miyazaki |
Organization
National Cardiovascular Center
Division name
Division of Cardiology
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cardiovascular Center
Division name
The Division of Atheroscierosis, Metabolism and Clinical Nutrition
Zip code
Address
TEL
06-6833-5012
Homepage URL
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2004 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 01 | Day |
Last modified on
| 2009 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000155
