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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180064

Registered date:19/03/2019

D-psicose for diabetic neuropathy

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedDiabetic neuropathy
Date of first enrollment08/12/2015
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)D-psicose is orally administered 3 times a day, 5 g once.

Outcome(s)

Primary OutcomeDifference in mean value of nerve conduction velocity at the 12th week after administration from the start of administration
Secondary OutcomeConducting physical findings (tendon reflex, vibration sense), laboratory findings (CV - RR), questionnaire survey.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriatype 2 diabetes patient over 20 years old who have diabetic neuropathy and can not obtain sufficient effect by any of the following treatments (HbA1c 6.5% or more and less than 8.0%) 1) Diet therapy or exercise therapy only 2) Pharmacotherapy in addition to diet therapy / exercise therapy
Exclude criteria1) Patients falling under D-psicose administration contraindications 2) Patients participating in other trials 3) A pregnant woman, a maternity woman, a lactating woman or a woman having a possibility of pregnancy 4) Patients who have poor glycemic control with HbA1c> 8% 5) Patients who have severe renal dysfunction (serum creatinine value> 1.5 mg / dl) 6) Patients with other serious complications 7) Patients judged inappropriate as subjects by other doctor's judgment 8) Patients undergoing drug therapy for diabetic neuropathy

Related Information

Contact

Public contact
Name Kensaku Fukunaga
Address 1750-1, Miki-cho, Kita-gun, Kagawa Kagawa Japan 761-0793
Telephone +81-87-891-2230
E-mail labmed@med.kagawa-u.ac.jp
Affiliation Faculty of Medicine, Kagawa University
Scientific contact
Name imachi hitomi
Address 1750-1, Miki-cho, Kita-gun, Kagawa Kagawa Japan 761-0793
Telephone +81-87-891-2230
E-mail labmed@med.kagawa-u.ac.jp
Affiliation Faculty of Medicine, Kagawa University