Trial to evaluate effects of the intention to treat for insulin resistance (ITT-IR) to prevent cardiovascular events in early stages of diabetes

Cluster randomized parallel controlled trial to evaluate effects of the intention to treat for insulin resistance (ITT-IR) to prevent cardiovascular events in early stages of diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11215387

Enrollment

604

Registered

2024-04-05

Start date

2016-04-05

Completion date

Unknown

Last updated

2024-04-22

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

Conditions

Early stages of diabetes Nutritional, Metabolic, Endocrine

Interventions

Intervention group (G-I): The protocols of I [self-monitoring of steps, of body weight and of blood pressure (BP), following of visceral fat area (V) in abdominal obese patients, diet advise by dietit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diabetes patients visited outpatient clinic in Wakayama Rosai Hospital from April to June in 2016

Exclusion criteria

Exclusion criteria: Cannot continue to visit our outpatient clinic

Design outcomes

Primary

Measure	Time frame
Measured using patient records at the end of study: Percutaneous coronary intervention, carotid endarterectomy, carotid artery stenting, endovascular treatment, thromboendarterectomy, coronary artery bypass grafting, ablation, implantable cardioverter defibrillator, clipping for aneurysm of intracranial arteries, amputation from gangrene, non-fatal stroke, non-fatal myocardial infarction(MI), hemodialysis, frailty, dementia, hospitalization from heart failure, death from cardiovascular causes, death from renal failure, death from frailty)	—

Measure

Time frame

Measured using patient records at the end of study: Percutaneous coronary intervention, carotid endarterectomy, carotid artery stenting, endovascular treatment, thromboendarterectomy, coronary artery bypass grafting, ablation, implantable cardioverter defibrillator, clipping for aneurysm of intracranial arteries, amputation from gangrene, non-fatal stroke, non-fatal myocardial infarction(MI), hemodialysis, frailty, dementia, hospitalization from heart failure, death from cardiovascular causes, death from renal failure, death from frailty)

—

Secondary

Measure	Time frame
Measured using patient records at the end of study: Hospitalization from complications or comorbidities, death)	—

Countries

Japan

Contacts

Public ContactTakashi Ohoshi

tks-oohoshi@wakayamah.johas.go.jp+81 734513181

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026