Type 2 diabetes mellitus. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: Vitamin E capsules (400 mg orally daily, once a day, Kimia Sanat) combined with metformin/insulin, for three months. Intervention 2: Control group: Placebo (400 mg
Sponsors
Shahre-kord University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diagnosed with type 2 diabetes for over 5 years Diagnosis of diabetes after the age of 30 Age 30-70 years Fasting blood glucose 126-180 mg/dL No corticosteroid and anticoagulant use in the past month No oral contraceptive use in the past month Individuals who have not taken vitamin E supplements at least twelve weeks before the test Individuals who are not professional athletes (whose profession is specialized sports, thus should dedicate most of their time, energy, and focus to their professional sport and earn their living through sports) Patients using melatonin, aspirin, D3, omega-3 during the study
Exclusion criteria
Exclusion criteria: Individuals with a history of stroke. Individuals diagnosed with cardiovascular disease. Individuals with a history of liver or kidney disease Pregnant women or breastfeeding mothers. Presence of congenital cognitive and anxiety disorders. Individuals taking medications related to severe depression (bipolar disorder). Patients with a history of dementia.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood sugar level. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: Photometric method. | — |
Primary
| Measure | Time frame |
|---|---|
| The average depression score. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: The Depression, Anxiety and Stress questionnaire (DASS 21).;The average anxiety score. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: The Depression, Anxiety and Stress questionnaire (DASS 21).;Average stress score. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: The Depression, Anxiety and Stress questionnaire (DASS 21).;Cortisol level. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: ELISA technique.;Malondialdehyde level. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: Thiobarbituric acid(TBA) technique.;Antioxidant capacity. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: Measurement of non-enzymatic antioxidant activity by fluorescence-based assay (FRAP).;Cognitive performance score. Timepoint: Before the intervention and three months after finishing taking vitamin E or placebo. Method of measurement: The Addenbrooke's Cognitive Examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Reihaneh Sadeghian
Kerman University of Medical Sciences
Outcome results
None listed