UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035104 |
|---|---|
| Receipt number | R000040014 |
| Scientific Title | Relationship between Sarcopenia and Oral Flail in Type 2 diabetic patients |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2023/05/16 03:20:57 |
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Basic information
Public title
Relationship between Sarcopenia and Oral Flail in Type 2 diabetic patients
Acronym
Relationship between Sarcopenia and Oral Flail in Type 2 diabetic patients
Scientific Title
Relationship between Sarcopenia and Oral Flail in Type 2 diabetic patients
Scientific Title:Acronym
Relationship between Sarcopenia and Oral Flail in Type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between sarcopenia and Oral Flail in type 2 diabetic patients
Basic objectives2
Others
Basic objectives -Others
Relationship between amount of physical activity and tongue pressure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength
Key secondary outcomes
Skeletal muscle mass
Amount of physical activity
Motor function
Tongue pressure
Glycemic control and lipid profile.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with type 2 diabetes
2)Diabetes education inpatients
3) Patients who can agree in writing with participation of research by free will.
Key exclusion criteria
1. Patients who could not adapt to the exercise therapy.
2. Patients who can not walk alone.
3. Patients with significant limitations in daily life
4. Patients with severe cardiovascular and respiratory disease
5. Patients with liver cirrhosis or renal failure (serum creatinine> 2.0 mg / dl)
6. Patients having acute and/or chronic orthopedic disease, and who were presently receiving medical treatment.
7. Patients having non-symmetry of bilateral lower-extremity muscular atrophy.
8. Patients having an impairment of the lower-extremities.
9. Patients having severe infectious disease.
10. In addition, patients judged unsuitable for researchers as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Amano |
Organization
Ehime prefectural central hospital
Division name
Department of Rehabilitation
Zip code
790-0024
Address
Kasuga-machi, Matsuyama city,Ehime
TEL
0899471111
epta.kouekijigyou.dm@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Amano |
Organization
Ehime prefectural central hospital
Division name
Department of Rehabilitation
Zip code
790-0024
Address
Kasuga-machi, Matsuyama city,Ehime
TEL
0899471111
Homepage URL
epta.kouekijigyou.dm@gmail.com
Sponsor or person
Institute
Ehime prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime prefectural central hospital
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
Ehime Prefectural Central Hospital, Clinical Research Review Committee Secretariat
Address
83, Kasuga-machi, Matsuyama city,Ehime
Tel
0899471111
c-volunteer@eph.pref.ehime.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 | 01 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000040014
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000040014
Number of participants that the trial has enrolled
100
Results
The66th Annual Meeting of the Japan Diabetes Society was presented.
There were 43 subjects with OF, and significant differences (p<0.05) were found between the OF and non-OF groups for age, gait speed, and knee extension muscle strength.
Binomial logistic regression analysis showed a significant difference (p<0.05) 95% CI (1.023-1.236) in age when the independent variables were age, gender, SMI, grip strength, and walking speed, with an odds ratio of 1.124.
Results date posted
| 2023 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Type 2 diabetes patients over 65 years old
Participant flow
1)Patients diagnosed with type 2 diabetes
2)Diabetes education inpatients
3)Patients who can agree in writing with participation of research by free will.
Adverse events
None
Outcome measures
Skeletal muscle mass
Amount of physical activity
Motor function
Tongue pressure
Glycemic control and lipid profile.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
To investigate the relationship between sarcopenia and Oral Flail in type 2 diabetic patients
Management information
Registered date
| 2018 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040014
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