Type 2 diabetes. Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention 1: Intervention group: D3 forte 1000 IU containing 1000 IU vitamin D3 and 100 mg magnesium elemental (as magnesium oxide) produced by Arian Salamat Sina Company twice a day for 12 weeks.
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Willing to participate and signing informed consent Diagnosis of diabetes by a specialist Stable blood glucose level defined by HbA1C< 8.5% Age 40-65 Patients who are currently under medication therapy At least 5 years history of type 2 diabetes
Exclusion criteria
Exclusion criteria: Having severe complications of diabetes such as amputation, blindness and dialysis Patients with malabsorption syndromes History of stroke, transient ischemic attack and lacunar infarction Patients with severe depression and anxiety, bipolar and psychosis Loss of consciousness for more than 5 minutes Having dementia, Parkinson's, schizophrenia, Huntington's, AIDS, HIV positive Patients with chronic diseases such as liver failure, thyroid diseases and cancer. Alcohol, smoking and drug use Pregnant and lactating women or women who intend to become pregnant Taking drugs affecting the CNS Any change in the patient's medicine or its dosage during the last 3 months before the trial Regular consumption of higher than RDA doses of magnesium and vitamin D supplements and other supplements during the 2 months prior to the intervention Taking medicine containing magnesium more than 150 mg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: MoCA (Montreal Cognitive Assessment) test.;Executive function. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Verbal fluency test.;Verbal memory. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Auditory Verbal Learning Test.;Attention. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Stroop Color and Word Test.;Information processing speed. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Stroop Color and Word Test.;CRP (C-Reactive Protein) level. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test. | — |
Secondary
| Measure | Time frame |
|---|---|
| FBS. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.;HbA1c. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.;25 (OH) Vit D. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: Laboratory test.;Blood pressure. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: sphyngomanometer.;Body composition. Timepoint: before intervention and after 12 weeks of intervention. Method of measurement: scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Arabpour
Iran University of Medical Sciences
Outcome results
None listed