?Diabetic peripheral neuropathy. Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group 1: Organic selenium group. They will take one 500 mg oral capsule containing 200 micrograms of selenium daily for 8 weeks. Organic selenium will be produced by the
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Women or men aged 40-70 years Type 2 Diabetes based on the diagnosis of endocrinologist Diabetic peripheral neuropathy based on Michigan neuropathy screening tool
Exclusion criteria
Exclusion criteria: Peripheral neuropathy due to other diseases (including alcohol consumption, chemotherapy, congenital disease, chronic inflammation, thyroid disorders, vitamin B12 deficiency, HIV, and idiopathic peripheral neuropathy) Other chronic diseases such as cancer, chronic renal failure, CVA, Parkinson, Alzheimer Increased risk of bleeding due to coagulation disorders Selenium or vitamin E supplementation during last 3 months Pregnancy Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathy symptoms. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Michigan neuropathy screening tool.;Neuropathy severity. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Toronto Clinical Scoring System.;Serum levels of glycemic markers (fasting blood sugar, insulin resistance, blood sugar monitored by the individual). Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Biochemical methods and glucometer.;Pro-oxidant antioxidant balance. Timepoint: Pro-oxidant antioxidant balance. Method of measurement: Biochemical method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: World Health Organization quality of life assessment instrument (WHOQOL -BREF).;Depression score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory-2.;Sleep quality score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;Sexual satisfaction score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Larson's sexual satisfaction questionnaire (LSSQ).;Side effects. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Questionnaire.;Satisfaction with medication. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Satisfaction rate questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzizeh Farshbaf-khalili
Tabriz University of Medical Sciences
Outcome results
None listed