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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029617
Receipt No. R000033409
Scientific Title Longitudinal study of the knee extension force for elderly patients with diabetes mellitus
Date of disclosure of the study information 2017/10/18
Last modified on 2019/04/21

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Basic information
Public title Longitudinal study of the knee extension force for elderly patients with diabetes mellitus
Acronym Multicenter survey of the isometric lower-extremity strength in type 2 diabetes: phase 2(MUSCLE-std2)
Scientific Title Longitudinal study of the knee extension force for elderly patients with diabetes mellitus
Scientific Title:Acronym Multicenter survey of the isometric lower-extremity strength in type 2 diabetes: phase 2(MUSCLE-std2)
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to examine the age-related loss of muscle strength and the influence of diabetic polyneuropathy in older patients with type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others Comprehensive management of high-risk patients with type 2 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee extension force
Key secondary outcomes 1. Characteristics: body weight, length of lower leg, height, age, and a non-dominant leg.
2. Diabetes treatment-related information: Duration of diabetes, fasting plasma glucose (or postprandial plasma glucose), HbA1c, LDL cholesterol, HDL cholesterol, total cholesterol, trygriceride, serum creatinine, fasting insulin, the administration of diet therapy and the details of such diet therapy, the use of drug therapy and the details of drug therapy.
3. Diabetic polyneuropathy by a simple diagnosis standard neuropathy test: achilles' tendon reflex, vibratory sense on medial malleolus, subjective symptoms.
4. Complications associated with diabetes, complications not related to diabetes.
5. Clarify and evaluate the patient's normal exercise patterns, drinking habit, and smoking habit.
6. Loco check 25, EQ-5D

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
60 years-old <=
Age-upper limit
92 years-old >
Gender Male and Female
Key inclusion criteria Inpatients and/or outpatients with type 2 diabetes, who give written informed consent to participate in the study.
Key exclusion criteria 1. Patients who could not adapt to the exercise therapy.
2. Independent walking is impossible.
3. Significant limitations in their activities of daily of living.
4. Severe heart and/or respiratory diseases.
5. Severe liver dysfunction and/or renal failure (serum creatinine over 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. Patients requiring surgical treatment.
11. Other conditions that resulted in the patients being considered to be ineligible by the researcher.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takuo
Middle name
Last name Nomura
Organization Kansai University of Welfare Sciences
Division name Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code 582-0026
Address 3-11-1, Asahigaoka, Kashiwara city, Osaka 582-0026, JAPAN
TEL 072-978-0088
Email tnomura@tamateyama.ac.jp

Public contact
Name of contact person
1st name Takuo
Middle name
Last name Nomura
Organization Kansai University of Welfare Sciences
Division name Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code 582-0026
Address 3-11-1, Asahigaoka, Kashiwara city, Osaka 582-0026, JAPAN
TEL 072-978-0088
Homepage URL http://ptdm.jp/
Email tnomura@tamateyama.ac.jp

Sponsor
Institute Kansai University of Welfare Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai University of Welfare Sciences
Address 3-11-1, Asahigaoka, Kashiwara city, Osaka 582-0026, JAPAN
Tel 072-978-0088
Email umin-kfk@tamateyama.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 公立豊岡病院日高医療センター(兵庫県)、公立陶生病院(愛知県)、製鉄八幡病院(福岡県)、市立伊丹病院(兵庫県)、金沢赤十字病院(石川県)、市立吹田市民病院(大阪府)、公立甲賀病院(滋賀県)、広島大学病院(広島県)、KKR高松病院(香川県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-15K01440/
Number of participants that the trial has enrolled
Results
1) There were 15 male and 11 female patients with diabetic neuropathy (DN), and there was no significant difference in the presence rate of DN according to gender. The rate of decrease in KEF was -2.9% on average in the group without DN, and -4.1% on average in the group with DN. Although the group with DN had a higher value, there were no significant differences between the two groups. In elderly patients with type 2 diabetes, a significant decrease in KEF due to DN was observed. In addition, DN can possibly accelerate decline in KEF in elderly diabetic patients on the basis of aging.

2) http://ptdm.jp/
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
2015 Year 10 Month 01 Day
Date of IRB
2015 Year 01 Month 15 Day
Anticipated trial start date
2015 Year 10 Month 17 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information KAKEN
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-15K01440/

1) Nomura T, Kawae T, Kataoka H, Ikeda Y: Assessment of lower extremity muscle mass, muscle strength, and exercise therapy in elderly patients with diabetes mellitus. Environ Health Prev Med 23(1):20, 2018.

2) Nomura T, Kawae T, Kataoka H, Ikeda Y: Aging, physical activity, and diabetic complications related to loss of muscle strength in patients with type 2 diabetes. Phy Ther Res 21(2):33-38, 2018.

Management information
Registered date
2017 Year 10 Month 18 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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