UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038538 |
|---|---|
| Receipt number | R000043673 |
| Scientific Title | Effects of EPA/DHA on skeltal muscle in geriatric type 2 diabetic patients on admission. |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2024/05/15 20:43:22 |
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Basic information
Public title
Effects of EPA/DHA on skeltal muscle in geriatric type 2 diabetic patients on admission.
Acronym
Effects of EPA/DHA on skeltal muscle in geriatric type 2 diabetic patients on admission.
Scientific Title
Effects of EPA/DHA on skeltal muscle in geriatric type 2 diabetic patients on admission.
Scientific Title:Acronym
Effects of EPA/DHA on skeltal muscle in geriatric type 2 diabetic patients on admission.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to assess the effects of EPA/DHA on skeltal muscle in geriatric type 2 diabetic patients on admission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
grasping power and creatinine/cystatin C ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Take Omega-3-acid ethyl esters everyday on admission
Interventions/Control_2
none
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 65 years of age or older
Patient's HbA1c is 8.0% and over
Patients who have dyslipidemia
Patients who provided informed consent and assent
Key exclusion criteria
Patients who have a history of hyperglicemic emergency, severe infecitous diseases, major surgery and severe trauma in the past 6 months
Patients who will undergo a surgery within 3 months
Patients who already take EPA/DHA
Patients who have EPA/DHA allergy
Patients suffering bleeding disease
Patient's eGFR is 30 and less
Patients who contact persons judge as ineligible for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Koyama |
Organization
Nagoya City University Graduate School of Medical Science
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 KAWASUMI, MIZUHO, NAGOYA, 467-8601, JAPAN
TEL
052-853-8211
hk0515@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Koyama |
Organization
Nagoya City University Graduate School of Medical Science
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 KAWASUMI, MIZUHO, NAGOYA, 467-8601, JAPAN
TEL
052-853-8211
Homepage URL
hk0515@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical 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
Clinical Research Management Center, Nagoya City University Hospital
Address
1 KAWASUMI, MIZUHO, NAGOYA, 467-8601, JAPAN
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2019 | Year | 11 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043673
