The investigation of norepinephrine/serotonin transporter in patients with painful diabetic neuropathy

Not Applicable

• Conditions: Painful diabetic neuropathy

• Registration Number: JPRN-UMIN000020876
• Lead Sponsor: ational Institute of Radiological Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 26

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relationship between painful diabetic neuropathy and binding potentials of norepinephrine/serotonin transporter in the brain

Secondary Outcome Measures

Name	Time	Method
The occupancy of norepinephrine/serotonin transporter, therapeutic effect, fMRI, cognitive function, physiological/psychological index