UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030945 |
|---|---|
| Receipt number | R000035340 |
| Scientific Title | Intervention study on flail and sarcopenia of elderly diabetic patients |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/07/26 13:35:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intervention study on flail and sarcopenia of elderly diabetic patients
Acronym
Research on rehabilitation nutrition for elderly diabetes
Scientific Title
Intervention study on flail and sarcopenia of elderly diabetic patients
Scientific Title:Acronym
Research on rehabilitation nutrition for elderly diabetes
Region
| Japan |
Condition
Condition
Frail and sarcopenia in diabetic patients
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine how nutritional intake and exercise therapy as an intervention in frail and sarcopenia affects the frail risk factor of elderly diabetic patients, furthermore to clarify the relation factors between those effects and clinical valuables.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Fraility Scale, Sarcopenia Evaluation factors(Grip strength, walking speed, muscle mass),Intervention period:3 months
Key secondary outcomes
blood test (blood collection within the general diagnostic range such as HbA1c value and blood sugar level, high sensitivity CRP, 25 (OH) vitamin D, prealbumin, DHEAS, Zn, Cu), urinalysis items (general medical items, urinary albumin), nutrition survey, MNA-SF, MMSE, Vitality Index, GDS 15, medical records.There is possibility to add or refer to noninvasive inspection items other than the above.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Diabetic nephropathy 1st, 2nd, 3rd: Meibalance Reha Support Mini (Meiji)
Diabetic nephropathy 4th: Aminocare jelly leucine 40 (Nestle Health Science)
Consume the above one everyday, in addition to exercise therapy twice a week
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diabetes patients over 65 years old who are visiting Muta Hospital
Key exclusion criteria
1: Those who are allergic to allergic indication components of nutritional supplements used in this study
2: Those who are extremely poor in general condition or those who are not permitted to exercise therapy from their doctor
3: Those who do not agree with this research
4: Persons who can not measure body composition with an inbody770 due to difficulty holding upright position
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuya Fujihara |
Organization
Seiwakai Muta Hospital
Division name
Internal medicine,Department of Diabetes Medicine
Zip code
Address
3-9-1, Hoshikuma, Sawara-ku, Fukuoka city,Fukuoka
TEL
092-865-2211
y-fujihara@seiwakai-muta-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuya Fujihara |
Organization
Seiwakai Muta Hospital
Division name
Internal medicine,Department of Diabetes Medicine
Zip code
Address
3-9-1, Hoshikuma, Sawara-ku, Fukuoka city,Fukuoka
TEL
092-865-2211
Homepage URL
y-fujihara@seiwakai-muta-hp.or.jp
Sponsor or person
Institute
Seiwakai Muta Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd., Nestle HealthScience Co., Ltd., Siemens Healthcare Diagnostics K.K.
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
| 2018 | Year | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035340
