UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010263 |
|---|---|
| Receipt number | R000010608 |
| Scientific Title | Investigation of impaired glucose tolerance using continuous glucose monitoring in patients with chronic heart failure |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2021/03/23 11:32:33 |
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Basic information
Public title
Investigation of impaired glucose tolerance using continuous glucose monitoring in patients with chronic heart failure
Acronym
Investigation of impaired glucose tolerance in patients with chronic heart failure
Scientific Title
Investigation of impaired glucose tolerance using continuous glucose monitoring in patients with chronic heart failure
Scientific Title:Acronym
Investigation of impaired glucose tolerance in patients with chronic heart failure
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of impaired glucose tolerance using continuous glucose monitoring in patients with chronic heart failure
Basic objectives2
Others
Basic objectives -Others
observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
continuous glucose monitoring, plasma levels of neurohormonal factors and proinflammatory cytokines
Key secondary outcomes
cardiac function, exercise capacity, skeletal muscle strength, body composition
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic heart failure.
Key exclusion criteria
Patients who were determined as being ineligible for the study by the investigators or sub investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kida |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL
0449778111
heart-kida@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kida |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
heart-kida@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
Tel
044-977-8111
heart-kida@marianna-u.ac.jp
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
| 2013 | Year | 03 | Month | 18 | 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
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective study
Management information
Registered date
| 2013 | Year | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010608
