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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035538
Receipt No. R000040491
Scientific Title Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes
Date of disclosure of the study information 2019/01/15
Last modified on 2019/01/15

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Basic information
Public title Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes
Acronym Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes (S-ROAD study)
Scientific Title Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes
Scientific Title:Acronym Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes (S-ROAD study)
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the prevalence and clinical features of sarcopenia in patients with type 2 diabetes in Japan.
Basic objectives2 Others
Basic objectives -Others To examine whether sarcopenia can be an independent risk factor for all deaths and cardiovascular disease (CVD) in patients with type 2 diabetes through a five-year prospective cohort study in Japan.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of any of all deaths and a composite of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attacks, heart failure, hospitalization for unstable angina, implementation of angioplasty for coronary, carotid, cerebrovascular or peripheral artery)
Key secondary outcomes * All deaths
* 4P-MACE (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina)
* Progression of microangiopathy (diabetic retinopathy, nephropathy)
* Arteriosclerosis Index (CAVI)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who satisfy all of the following criteria.
(1) Type 2 diabetes
(2) Lower age limit: 20 years old
(3) Gender: male and female
(4) Outpatients visiting hospitals of the National Hospital Organization
(5) Patients who have provided written informed consent
Key exclusion criteria Patients who fall under any of the following criteria.
(1) Patients with AST or ALT above 100 U/L
(2) Patients with Cre above 3.0 mg/dL
(3) Female patients who are suspected of being pregnant or pregnant
(4) Patients with previous history of angioplasty and bypass surgery, history of hospitalization for heart failure treatment within the past one year
(5) Patients with cancer with a history or treatment within five years
(6) Patients taking corticosteroids
(7) Patients with defects in their limbs
(8) Patients wearing pacemakers
(9) Patients judged by the investigator/project leader to be ineligible for other reasons
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Kusakabe
Organization National Hospital Organization Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Email kusakabe@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Kusakabe
Organization National Hospital Organization Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Homepage URL
Email kusakabe@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 H30-NHO(Diabetes)-03
Org. issuing International ID_1 National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 函館病院(北海道)、仙台医療センター(宮城県)、渋川医療センター(群馬県)、埼玉病院(埼玉県)、千葉東病院(千葉県)、京都医療センター(京都府)、神戸医療センター(兵庫県)、姫路医療センター(兵庫県)、徳島病院(徳島県)、小倉医療センター(福岡県)、九州医療センター(福岡県)、長崎病院(長崎県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 01 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 Main observation items:
1) Physical findings: height, weight, systolic and diastolic blood pressure, pulse
2) Sarcopenia related index: skeletal muscle index (SMI), grip strength
3) Obesity related index: body fat mass, percent body fat, body mass index (BMI), abdominal circumference, visceral and subcutaneous fat area
4) Blood tests: fasting plasma glucose, fasting insulin, HOMA-R, HbA1c, TP, Alb, AST, ALT, gGTP, BUN, Cre, eGFR, UA, T-cho, TG, HDL, LDL
5) Urinalysis: test paper method, urinary albumin / creatinine ratio
6) interview: age, gender, smoking history, alcohol intake history, family history, duration of diabetes, diabetic complications (retinopathy, nephropathy, neuropathy), history of other than diabetes, drugs for diabetes, dyslipidemia and hypertension
7) Evaluation of nutritional status: brief-type self-administered diet history questionnaire (BDHQ)
8) Evaluation of Physical Activity: International Physical Activity Questionnaire (IPAQ)

Management information
Registered date
2019 Year 01 Month 14 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040491

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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