D-psicose for diabetic neuropathy

JRCT ID: jRCTs061180064

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic neuropathy
• Date of first enrollment: 08/12/2015
• Target sample size: 30
• Study type: Interventional
• Intervention(s): D-psicose is orally administered 3 times a day, 5 g once.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

type 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 criteria

1) 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

• Primary Sponsor: hitomi imachi