Asahi Diabetes Complications Study

Asahi Diabetes Complications Study - Asahi Diabetes Complications Study (Asahi study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015744

Enrollment

2000

Registered

2014-11-26

Start date

2014-11-27

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 and type 2 diabetes mellitus

Exclusion criteria

Exclusion criteria: 1)Patient without diabetes 2)Impaired glucose tolerance 3)Other types of diabetes mellitus due to specific causes 4)Gestational diabetes mellitus 5)Overt diabetes in pregnancy 6)Patients who are difficult to judge whether to participate in the study 7)Patient judged inappropriate for the doctor in charge

Design outcomes

Primary

Measure	Time frame
1.Nephropathy The first period: consecutive 2 measured albuminuria in patients without microalbuminuria (urinary albumin/ creatinine ratio, 30mg/g Cr or greater) The second period: appearance of overt proteinuria (urinary albumin/ creatinine ratio, 300mg/g Cr or greater), > 2-fold increases in serum creatinine, eGFR 30 ~ 40% reduction, or initiation of dialysis in those with microalbuminuria. 2. Retinopathy Development of retinopathy or progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness. 3. Macroangiopathy Ischemic heart disease (e.g. cardiac revascularization, myocardial infraction), heart failure requiring hospitalization, cerebrovascular disease (e.g. cerebral hemorrhage or cerebral infarction requiring hospitalization) except transient cerebral ischemic attack. Lower extremity amputation, peripheral revascularization. 4. Malignancy Mortality from malignant tumor (hepatocellular carcinoma, pancreatic carcinoma, colorectal cancer etc.) 5. Mild cognitive impairment Appearance of mild cognitive impairment (MOCA-J score of 25 or less) 6.Sarcopenia Appearance of sarcopenia (AGWS: Diagnostic criteria for sarcopenia in Asians) 7. Decline in ADL DASC8 (Category 1: 10 points or less, Category 2: 11-16 points, Category 3: 17 points or more)	—

Measure

Time frame

1.Nephropathy The first period: consecutive 2 measured albuminuria in patients without microalbuminuria (urinary albumin/ creatinine ratio, 30mg/g Cr or greater) The second period: appearance of overt proteinuria (urinary albumin/ creatinine ratio, 300mg/g Cr or greater), > 2-fold increases in serum creatinine, eGFR 30 ~ 40% reduction, or initiation of dialysis in those with microalbuminuria. 2. Retinopathy Development of retinopathy or progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness. 3. Macroangiopathy Ischemic heart disease (e.g. cardiac revascularization, myocardial infraction), heart failure requiring hospitalization, cerebrovascular disease (e.g. cerebral hemorrhage or cerebral infarction requiring hospitalization) except transient cerebral ischemic attack. Lower extremity amputation, peripheral revascularization. 4. Malignancy Mortality from malignant tumor (hepatocellular carcinoma, pancreatic carcinoma, colorectal cancer etc.) 5. Mild cognitive impairment Appearance of mild cognitive impairment (MOCA-J score of 25 or less) 6.Sarcopenia Appearance of sarcopenia (AGWS: Diagnostic criteria for sarcopenia in Asians) 7. Decline in ADL DASC8 (Category 1: 10 points or less, Category 2: 11-16 points, Category 3: 17 points or more)

—

Secondary

Measure	Time frame
1.all-cause mortality 2.complication retinopathy: photocoagulation, vitreous surgery, blindness neuropathy: ulcer or gangrene malignancy: incidence of malignancy 3.medical expenses	—

Countries

Japan

Contacts

Public ContactYoko Yoshida

The Institute of Medical Science, Asahi Life Foundation Division of Diabetes and Metabolism

y-yoshida@asahi-life.or.jp03-3639-5501

Outcome results