Japan Diabetes Complication and its Prevention Prospective Study

Japan Diabetes Complication and its Prevention Prospective Study - JDCPstudy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016519

Enrollment

6500

Registered

2015-02-16

Start date

2007-06-01

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

Diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) type 1&2 Diabetes 2) 40-< 75 years old

Exclusion criteria

Exclusion criteria: 1) patients who can't see a doctor regularly 2) proliferative retinopathy 3) patients who undergo artificial dialysis 4) patients who is diagnosed as cancer in last 5 years 5) patients who is judged as isn't proper

Design outcomes

Primary

Measure	Time frame
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, or initiation of dialysis in those with microalbuminuria. Retinopathy Progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness Neuropathy Lower extremity amputation associated with peripheral neuropathy Macroangiopathy Ischemic heart disease (e.g. myocardial infraction, angina, cardiac revascularization), cerebrovascular disease (e.g. stroke, transient cerebral ischemic attack), heart failure, ASO, and lower extremity amputation (without peripheral neuropathy) Periodontal disease New appearance of probing depth [PD] 4mm or deeper or loss of a tooth due to periodontal disease Surrogate endpoints Gingival swelling, number of intact teeth, number of sites with clinical attachment level [CAL] 4 mm or greater, number of sites with bleeding on proving [BOP], maximum alveolar bone resorptions as assessed by orthopantomography	—

Measure

Time frame

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, or initiation of dialysis in those with microalbuminuria. Retinopathy Progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness Neuropathy Lower extremity amputation associated with peripheral neuropathy Macroangiopathy Ischemic heart disease (e.g. myocardial infraction, angina, cardiac revascularization), cerebrovascular disease (e.g. stroke, transient cerebral ischemic attack), heart failure, ASO, and lower extremity amputation (without peripheral neuropathy) Periodontal disease New appearance of probing depth [PD] 4mm or deeper or loss of a tooth due to periodontal disease Surrogate endpoints Gingival swelling, number of intact teeth, number of sites with clinical attachment level [CAL] 4 mm or greater, number of sites with bleeding on proving [BOP], maximum alveolar bone resorptions as assessed by orthopantomography

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Countries

Japan

Contacts

Public ContactRimei Nishimura

The Jikei University School of Medicine Diabetic tract medicine

rimei.nishimura@gmail.com03-3433-1111

Outcome results