D-psicose for diabetic neuropathy
- Conditions
- Diabetic neuropathy
- Registration Number
- JPRN-jRCTs061180064
- Lead Sponsor
- hitomi imachi
- Brief Summary
In this study, which evaluated the difference in mean nerve conduction velocity from the start of administration to 12 weeks after administration, the results showed that additional administration of D-psicose did not exacerbate diabetic neuropathy. This was a test of the hypothesis that diabetic neuropathy is not exacerbated, but as a subject of this study, we believe that more detailed analysis was possible once the target number of target cases was reached.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in mean value of nerve conduction velocity at the 12th week after administration from the start of administration
- Secondary Outcome Measures
Name Time Method Conducting physical findings (tendon reflex, vibration sense), laboratory findings (CV - RR), questionnaire survey.