UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000002810
Receipt No. R000003406
Scientific Title The establishment of a reference standard value for lower-extremity strength in patients with type 2 diabetes to clinically evaluate both the degree of diabetic complications and the effectiveness of exercise therapy
Date of disclosure of the study information 2009/11/30
Last modified on 2019/09/30 (Ver. 46)

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Basic information
Public title The establishment of a reference standard value for lower-extremity strength in patients with type 2 diabetes to clinically evaluate both the degree of diabetic complications and the effectiveness of exercise therapy
Acronym Multicenter survey of the isometric lower-extremity strength in type 2 diabetes (MUSCLE-std)
Scientific Title The establishment of a reference standard value for lower-extremity strength in patients with type 2 diabetes to clinically evaluate both the degree of diabetic complications and the effectiveness of exercise therapy
Scientific Title:Acronym Multicenter survey of the isometric lower-extremity strength in type 2 diabetes (MUSCLE-std)
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 To measure the knee extension force of type 2 diabetes patients in a multicenter study and establish a reference standard value, using a general method in which the reliability and the validity have been established.
Basic objectives2 Others
Basic objectives -Others To provide a reference standard value of knee extension force and thereby contribute to the evaluation of diabetic polyneuropathy (DP), and to develop appropriate exercise intervention strategies and the determination of its treatment effects for individuals with type 2 diabetes mellitus.
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.

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
30 years-old <=
Age-upper limit
89 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 1200

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, 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, Osaka 582-0026, Japan
TEL 072-978-0088
Homepage URL
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 Japan

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, 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 石川県立中央病院（石川県）、公立豊岡病院日高医療センター（兵庫県）、公立八鹿病院（兵庫県）、KKR高松病院（香川県）、キナシ大林病院（香川県）、四万十市立市民病院（高知県）、高知大学医学部附属病院（高知県）、社会医療法人愛仁会千船病院（大阪府）、高知県立あき総合病院（高知県）、市立伊丹病院（兵庫県）、市立吹田市民病院（大阪府）、東京医科大学八王子医療センター（東京都）、医療法人仁寿会石川病院（兵庫県）、聖マリアンナ医科大学病院（神奈川県）、公立甲賀病院（滋賀県）、総合病院南生協病院（愛知県）、公立陶生病院（愛知県）、大阪労災病院治療就労両立支援センター（大阪府）、春日井市民病院（愛知県）、金沢赤十字病院（石川県）、広島大学病院（広島県）、恒昭会藍野病院（大阪府）、長野医療生活協同組合長野中央病院（長野県）、北里大学病院（神奈川県）、京都南病院（京都府）、製鉄記念八幡病院（福岡県）、岡崎市民病院（愛知県）、さいたま市民医療センター（埼玉県）、総合大雄会病院（愛知県）、丸子中央総合病院（長野県）

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 30 Day

Related information
URL releasing protocol http://www.scirp.org/journal/JDM/
Publication of results Published

Result
URL related to results and publications http://kaken.nii.ac.jp/d/r/30423479.ja.html
Number of participants that the trial has enrolled 1704
Results 
1) https://www.growkudos.com/publications/10.1111%25252Fjdi.12658/reader

2) http://ptdm.jp/muscle/
Results date posted
2019 Year 09 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Inclusion criteria consisted of type 2 diabetes patients aged 30 to 89 years visiting a hospital on either an inpatient or outpatient basis. Exclusion criteria included the following: inability to adapt to exercise therapy, inability to walk independently, significant limitations in activities of daily of living, severe heart and/or respiratory diseases, severe liver dysfunction and/or renal failure (serum creatinine >2.0 mg/dL), patients with acute or chronic orthopedic disease who were presently receiving medical treatment, nonsymmetry of bilateral lower extremity muscular atrophy, impairment of the lower extremities, severe infectious disease, or patients requiring surgical treatment.
Participant flow 
In the Multicenter Survey of the Isometric Lower Extremity Strength in Type 2 Diabetes Study, we collected data from 30 hospitals in Japan between April 2010 and March 2015.
Adverse events 
None.
Outcome measures 
Diabetes assessment (diabetes duration, HbA1c, diabetic complications, etc.); Knee extension force assessment (maximum isometric force); Habitual behavior assessment (exercise behavior, smoked and alcohol drinkers)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 10 Month 21 Day
Date of IRB
2009 Year 10 Month 21 Day
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information 1) Nomura T, Ishiguro T, Ohira M, Ikeda Y. Diabetic polyneuropathy is a risk factor for decline of lower extremity strength in patients with type 2 diabetes. J Diabetes Investig. 2018 Jan;9(1):186-192. doi: 10.1111/jdi.12658. Epub 2017 May 6.

2) Nomura T, Ishiguro T, Ohira M, Ikeda Y. Regular exercise behavior is related to lower extremity muscle strength in patients with type 2 diabetes: data from the MUSCLE-std study. J Diabetes Investig. 2018 Mar;9(2):426-429. doi: 10.1111/jdi.12703. Epub 2017 Jul 23.

3) Nomura T, et al.: Isometric knee extension force in Japanese type 2 diabetic patients without apparent diabetic polyneuropathy: data from the Multicenter Survey of the Isometric Lower Extremity Strength in Type 2 Diabetes study. SAGE Open Medicine 2019 7:1-8. doi: 10.1177/2050312118823412. First Published January 8, 2019

Management information
Registered date
2009 Year 11 Month 29 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003406