Effects of folate supplementation on on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease

The aim of this study is to determine the effects of folate supplementation on carotid intima media thickness (CIMT), metabolic profiles, inflammatory factors and biomarkers of oxidative stress among type 2 diabetes patients with coronary heart disease (CHD).

Study design: Parallel double-blind randomized controlled clinical trial.

Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.

Inclusion criteria: Invituals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Intake of folate supplements within the last 3 months, acute myocardial infarction within the past 3 months, cardiac surgery within the past 3 months, renal or liver failure.

Intervention: Patients will be assigned to receive either 5 mg/day folate supplements (intervention group: n=30) or placebo (control group: n=30).

Outcomes: Biomarkers of insulin metabolism (primary outcome) and glucose homeostasis parameters, lipid profiles, biomarkers of inflammation and oxidative stress (secondry outcomes) will be quantified at the study baseline and end-of-trial.

Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.

Kashan University of Medical Sciences

At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take folate supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.

Participants, investigators or the assessors of the outcomes are unaware of the study groups.Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.