Effects of folate supplementation on on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Objective: 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. Inclusion and Exclusion Criteria: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Individuals with neurological and physical problems such as kidney disease coupled with heart disease, patients in addition with heart disease facing chronic pain from reins, rheumatism Etc and patients who were used from psychiatric drugs simultaneously will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 5 mg/day folate supplements (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 12-wk intervention. Fasting blood samples will be taken at baseline and after 12-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 12 weeks (April 9, 2015-July 9, 2015). Outcomes: Fasting plasma glucose (FPG), serum insulin, lipid profiles, inflammatory factors and biomarkers of oxidative stress will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503175623N40
Registration date:2015-03-28, 1394/01/08
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-03-28, 1394/01/08
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2015-04-08, 1394/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of folate supplementation on on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Public title
Effect of supplementation in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects aged 45-75 years; diagnosed with type 2 diabetes and CVD.
Exclusion Criteria: Patients with neurological and physical problems such as kidney disease coupled with heart disease; patients in addition with heart disease facing chronic pain from reins, rheumatism Etc; patients who were used from psychiatric drugs simultaneously.