The Impact on Surrogate Markers by therapeutic changes IN lifeSTyle rElAted Diseases (ISM-Tx INSTEAD)

The Impact on Surrogate Markers by therapeutic changes IN lifeSTyle rElAted Diseases (ISM-Tx INSTEAD) - ISM-Tx INSTEAD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012418

Enrollment

500

Registered

2013-11-27

Start date

2013-11-28

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

Diabetes Mellitus Hypertention Dyslipidemia Smoking

Interventions

anti-diabetic agent anti-hypertensive agent lipid therapeutic agent antiplatelet agent smoking-cessation aid admission

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with diabetes 2)Patients needed to be intervened 3)Patients without any therapeutic change for 4 weeks before intervention 4)Patients agree to entry to the study

Exclusion criteria

Exclusion criteria: Patients with: 1)anaphylaxis to the intended therapy 2)contraindication to the intended therapy 3)severe ketoacidosis, diabetic coma and pre-coma 4)severe renal dysfunction CCR<=30ml/min, SCr >2.5mg/dl(male),>2.0mg/dl(female) 5)severe infection, pre- and post-operation, severe injury 6)pregnancy, lactation, and 7)expected cessation of intended therapy or expected addition of other therapy 8)other contraindication

Design outcomes

Primary

Measure	Time frame
Change of surrogate markers in each group	—

Secondary

Measure	Time frame
Change of disease markers in each group	—

Countries

Japan

Contacts

Public ContactAkifumi Kushiyama

The Institute for Adult Diseases, Asahi Life Foundation Diabetes and Metabolism

kusiyaa-tky@umin.ac.jp03-3639-5501

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026