The effect of supplementation with organic selenium, vitamin E, and organic selenium-vitamin E on peripheral neuropathy and biochemichal markers in people with melitus diabetes.

Phase 3

Conditions: ?Diabetic peripheral neuropathy.
Polyneuropathy in diseases classified elsewhere
G63*

Registration Number: IRCT20131009014957N10

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europathy 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 Outcome Measures

Name	Time	Method
DHEA serum levels. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using Elisa method.;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.