Painful diabetic neuropathy
Conditions
Interventions
Medication of duroxetine
Sponsors
National Institute of Radiological Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetic neuropathy Patients who were diagnosed type 2 diabetes mellitus ?Patients complaining of neuropathic pain in the bilateral feet ( not includes only symptom of arms, coldness). ?Patients excluded other diagnoses which cause neuropathic pain. ?Patients with more than one month duration of symptom. ?Patients who understand written informed consent. Healthy individuals ?Persons with no history of mental diseases. ?Persons with no history of diabete mellitus and other serious physical diseases. ?Persons who understand written informed consent.
Exclusion criteria
Exclusion criteria: Diabetic neuropathy ?Patients taking pregabalin, carbamazepine, mexiletine within a weeks from registration. ?Patients taking monoamine oxidase inhibitor within two weeks from registration. ?Patients who showed a significant glycemic improvement by the treatment within four weeks from registration. ?Patients who are likely to experience significant glycemic improvement during the test period. ?Patients who are likely to require hospitalizations due to poor glycemic control. ?Patients with the involvement of alcoholic neuropathy. ?Patients with history of drug abuse or addiction. ?Patients with severe complications (cardiac failure, renal failure, hepatic failure, hemorrhagic peptic ulcers,bowel obstruction, malignant tumor, glaucoma.) ?Patients with pregnancy or desire to bear children. ?Patients with allergic history to duloxetine ?Patients who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, etc). ?Patients with strong claustrophobia ?Patients with history of treatment to depression, bipolar disorder, anxiety disorder, anorexia nervosa within one year prior to the registration. ?Patients corresponding to both of PHQ-2, or PHQ-9 score >15. Patients considered inappropriate by investigators Healthy individuals ?Persons with pregnancy or desire to bear children. ?Persons who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, etc). ?Persons with strong claustrophobia ?Patients within 6 months after the last injection of radioisotopes ?Patients considered inappropriate by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The relationship between painful diabetic neuropathy and binding potentials of norepinephrine/serotonin transporter in the brain | — |
Secondary
| Measure | Time frame |
|---|---|
| The occupancy of norepinephrine/serotonin transporter, therapeutic effect, fMRI, cognitive function, physiological/psychological index | — |
Countries
Japan
Contacts
Public ContactKazuko Suzuki
National Institute of Radiological Sciences Molecular Imaging Center
Outcome results
None listed