Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)

Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN) - Study on clinical signs and biomarkers of diabetic polyneuropathy (DPN)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046558

Enrollment

100

Registered

2022-01-11

Start date

2020-12-22

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

diabetic polyneuropathy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 1 and type 2 diabetic patients whose presence or absence of neuropathy was determined by simplified diagnostic criteria for diabetic polyneuropathy 2. Japanese adult men and women 3. Patients who can evaluate mTCNS 4. Patients with HbA1c value of 10.0% or less 5. Patients who have written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients with non-diabetic peripheral neuropathy 2. Patients with pain symptoms other than DPN in the lower limbs 3. Patients with overt central neurodegenerative disease (dementia, acute cerebral infarction, etc.) 4. Patients who are judged to have the possibility of changing treatment methods (drug therapy, etc.) for diabetes during the clinical study period 5. Patients judged by the attending physician to be inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
1.modified Tront Clinical Neuropathy Score 2. plasma biomarker concentration	—

Countries

Japan

Contacts

Public ContactTatsuhito Himeno

Aichi Medical University School of Medicine Division of Diabetes, Department of Internal Medicine

thimeno@aichi-med-u.ac.jp0561-63-1683

Outcome results