Quantitative examination of pain threshold of intra-epidermal nerve terminal for diagnosis and staging of diabetic polyneuropathy

Quantitative examination of pain threshold of intra-epidermal nerve terminal for diagnosis and staging of diabetic polyneuropathy - Pain threshold of intra-epidermal nerve terminal in diabetic polyneuropathy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025938

Enrollment

Registered

2017-02-01

Start date

2016-10-01

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

Diabetic polyneuropathy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Group 1: non-diabetic patients Group 2: type 2 diabetic patients with HbA1c<=13.0% Subgroup 2-1: without diabetic polyneuropathy Subgroup 2-2: with diabetic polyneuropathy Diagnosis of diabetic polyneuropathy is based on "simplified diagnostic criteria of diabetic polyneuropathy and suggested staging" proposed from the consensus of the Japanese study group of diabetic neuropathy

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation 2. Type 1 diabetes, other types of diabetes 3. Suffering from diabetic ketoacidosis 4. Severe infection, Severe injuries 5. Implanted a pacemaker, a defibrillator, or cochlear implant 6. Treatment with steroids 7. Current/Past malignancy 8. Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
1. Pain threshold of intra-epidermal nerve terminal 2. Corneal confocal microscopic findings 3. Nerve conduction studies Relationship of these three examinations	—

Secondary

Measure	Time frame
1. Score of Michigan Neuropathy Screening Instrument(MNSI) 2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation 3. HbA1c, blood glucose 4. Coefficients of variance of RR intervals 5. Diabetic nephropathy, Diabetic retinopathy 6. Laboratory data, blood pressure 7. Safety 8. Iriscorder 9. Elctroretinography 10. Somatosensory evoked potentials; SEP	—

Countries

Japan

Contacts

Public ContactHideki Kamiya

Aichi Medical University Diabetes

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

Outcome results