UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035859
Receipt number R000031902
Scientific Title Investigation of factors affecting declining physical function of type 2 diabetic patients
Date of disclosure of the study information 2019/02/14
Last modified on 2019/02/12 20:26:22

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Basic information

Public title

Investigation of factors affecting declining physical function of type 2 diabetic patients

Acronym

Investigation of factors affecting declining physical function of type 2 diabetic patients

Scientific Title

Investigation of factors affecting declining physical function of type 2 diabetic patients

Scientific Title:Acronym

Investigation of factors affecting declining physical function of type 2 diabetic patients

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

Investigated the association of HbA1c levels of type 2 diabetes mellitus patients with amount of physical activity and physical function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Isometric knee extension
June, Heisei 28 - October Heisei 29

Key secondary outcomes

The short Japanese version of the International Physical Activity Questionnaire:IPAQ
grip strength
Short Physical Performance Battery:SPPB score
4 m walking speed
5 times sit to stand test
Michigan Neuropathy Screening Instrument:MNSI
age
sex
disease duration
body mass index:BMI
HbA1c
eGFR
neutral fat
HDL-C
LDL-C
diabetic retinopathy and nephropathy status
hypoglycemic agent use and insulin therapy status


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

50 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Type 2 diabetic patients visiting Niigata Rinko Hospital and Niigata Bandai Hospital for diabetes outpatient

Key exclusion criteria

Patients who had difficulty in walking because of either locomotor disorders or central nervous disorders, patients with severe respiratory or circulatory disorders, patients with decreased cognitive function, patients who lacked measurement items, and patients who did not give their personal consent for participation, were all excluded as subjects.

Target sample size

109


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Shirai

Organization

Niigata Rinko Hospital, Niigata, Japan

Division name

Department of Rehabilitation

Zip code


Address

Momoyama-cho 1-114-3, Higashi-ku, Niigata City

TEL

025-274-5331

Email

shiraino9@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyuki Shirai

Organization

Niigata Rinko Hospital, Niigata, Japan

Division name

Department of Rehabilitation

Zip code


Address

Momoyama-cho 1-114-3, Higashi-ku, Niigata City 950-8725, Japan

TEL

025-274-5331

Homepage URL


Email

shiraino9@gmail.com


Sponsor or person

Institute

Niigata Rinko Hospital, Niigata, Japan

Institute

Department

Personal name



Funding Source

Organization

Niigata Rinko Hospital, Niigata, Japan

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


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

2806-51

Org. issuing International ID_1

Niigata Rinko Hospital, Niigata, Japan

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 02 Month 14 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

2016 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

These results suggest the possibility that the strength of the lower limbs can be increased by orientating Type 2 diabetes patients who only come to the hospital for regular monitoring, to promote a higher level of physical activity; this can contribute to preventing a decline in physical functions.


Management information

Registered date

2019 Year 02 Month 12 Day

Last modified on

2019 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031902


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name