UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035538 |
|---|---|
| Receipt number | 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 | 2023/07/19 15:53:01 |
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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 | Toru |
| Middle name | |
| Last name | Kusakabe |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-855
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
kusakabe@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kusakabe |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
kusakabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
National Hospital Organization
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
Kenkyu2004@hosp.go.jp
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
306
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040491
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