Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes

Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes - Study on the significance of sarcopenia as a risk of all deaths and cardiovascular disease in patients with type 2 diabetes (S-ROAD study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035538

Enrollment

1100

Registered

2019-01-15

Start date

2019-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
* All deaths * 4P-MACE (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina) * Progression of microangiopathy (diabetic retinopathy, nephropathy) * Arteriosclerosis Index (CAVI)	—

Countries

Japan

Contacts

Public ContactToru Kusakabe

National Hospital Organization Kyoto Medical Center Clinical Research Institute

kusakabe@kuhp.kyoto-u.ac.jp075-641-9161

Outcome results