UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008386 |
|---|---|
| Receipt number | R000009858 |
| Scientific Title | Double-blind randomized cross-over trial to assess the efficacy and safety of subcutaneous ghrelin in diabetic patients with cardiac autonomic dysfunction |
| Date of disclosure of the study information | 2012/07/09 |
| Last modified on | 2012/07/09 15:13:44 |
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Basic information
Public title
Double-blind randomized cross-over trial to assess the efficacy and safety of
subcutaneous ghrelin in diabetic patients with cardiac autonomic dysfunction
Acronym
Effect of subcutaneous ghrelin on diabetic autonomic neuropathy
Scientific Title
Double-blind randomized cross-over trial to assess the efficacy and safety of
subcutaneous ghrelin in diabetic patients with cardiac autonomic dysfunction
Scientific Title:Acronym
Effect of subcutaneous ghrelin on diabetic autonomic neuropathy
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
Recent studies suggest the effect of ghrelin on cardiac autonomic nervous function. The purpose of the present study is to examine the efficacy and safety of ghrelin treatment on diabetic autonomic neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Safety
2. Changes in autonomic function indices by heart rate variability using power spectrum analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subcutaneous ghrelin injection
Interventions/Control_2
Subcutaneous placebo injection
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus with
1. age of 40 years old or over
2. systolic blood pressure of 110 mmHg or over
3. resting heart rate of 60 bpm or over
4. compliance to dietary restriction
5. written informed consent
Key exclusion criteria
1. recent acute cardiovascular or cerebrovascular event
2. severe cardiac dysfunction
3. severe pulmonary dysfunction
4. active hepatitis or cirrhosis
5. severe kidney dysfuntion
6. severely impaired glucose control
7. untreated retinopathy
8. active infection
9. pregnancy
10. severe neuropathy
11. malignancy
12. severe arrhythmia
13. other reasons decided by physician
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Kishimoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-7-1 Fujishiro-dai, Suita City, Osaka, Japan
TEL
0668335012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Endocrinology and Metabolism
Zip code
Address
TEL
Homepage URL
kishimot@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 09 | 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 | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 09 | Day |
Last modified on
| 2012 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009858
