Type 2 diabetes. Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention 1: Intervention group: In this group, 38 people with a history of type 2 diabetes for over ten years take 1000 microgram/day B12 and 400 microgram/day folic acid for 12 weeks. Interventio
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnosis of diabetes by a specialist and based on the laboratory results for HA1C and 2HPG At least ten years of history of diabetes Stable blood glucose level defined by HbA1C< 8.5% Taking Metformin Age between 40 to 65 years old Willing and able to participate in the study until the end Educated enough to answer the tests
Exclusion criteria
Exclusion criteria: Visual and hearing problems Taking medications effective on CNS Any uncontrolled disease based on the participant's biography including malabsorption, stroke, TIA, psychoses, peripheral neuropathy, losing consciousness, high anxiety, clinical depression, mania, dementia, Parkinson, Huntington, schizophrenia, or other chronic illnesses such as liver failure, thyroid diseases, advanced kidney complications, cancer, etc. Smoking cigarettes and taking other abusive drugs Any change in the patient's medicine or its dosage during the last 3 months before the trial Taking folate or other supplementations that interfere with the intervention since the last 2 months before the start of trial Pregnancy or breastfeeding or the intention to get pregnant Any acute illnesses a month prior to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum HCY. Timepoint: At the beginning of the study (before intervention), after 12 weeks of taking folate and B12 supplements. Method of measurement: Laboratory test.;Cognition. Timepoint: At the beginning of the study (before intervention), after 12 weeks of taking folate and B12 supplements. Method of measurement: MoCA test.;CRP. Timepoint: At the beginning of the study (before intervention), after 12 weeks of taking folate and B12 supplements. Method of measurement: Laboratory test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression. Timepoint: Beginning and end of intervention. Method of measurement: Beck questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Mehdipoor
Iran University of Medical Sciences
Outcome results
None listed