The study to evaluate effects of a short term improvement of hyperglycemia in diabetic polyneuropathy

The study to evaluate effects of a short term improvement of hyperglycemia in diabetic polyneuropathy - Short term glycemic control and diabetic polyneuropathy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021914

Enrollment

Registered

2016-04-16

Start date

2015-12-01

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: Correspond to all of the following in recruitment of participants with type 2 diabetes: 1. Patients whose hospitalization periods are expected more than two weeks. 2. Patients who meets more than 2 of 3 below: i) Bilateral neuropathic symptom of lower extremities ii) Bilateral decreased vibration sensation of lower extremities iii) Bilateral decrease or absence of Achilles tendon reflexes. 3. HbA1c >= 8.0%

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation 2. Severe infection, Severe injuries 3. Treatment with steroids 4. Current/Past malignancy 5. Allergic to anesthetic drugs 6. Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
1. Change from screening in corneal confocal microscopic findings at week 2 and month 36 2. Change from screening in nerve conduction studies at week 2 and month 36	—

Secondary

Measure	Time frame
Changes from screeining in tests as below at week 2 and month 36 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. Current potential threshold 9. Iriscorder 10. Elctroretinography	—

Measure

Time frame

Changes from screeining in tests as below at week 2 and month 36 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. Current potential threshold 9. Iriscorder 10. Elctroretinography

—

Countries

Japan

Contacts

Public ContactHideki Kamiya

Aichi Medical University Diabetes

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

Outcome results