Folic Acid and Vitamin B12 in Diabetes

Phase 3

Recruiting

• Conditions: Type 2 diabetes.; Type 2 diabetes mellitus with neurological complications; E11.4

• Registration Number: IRCT20090901002394N48
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 76

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Depression. Timepoint: Beginning and end of intervention. Method of measurement: Beck questionnaire.