This randomized, two-arm, parallel clinical trial was carried out in Kashan,
Iran, from April 2011 to December 2011. On the basis of the sample size formula
suggested for randomized clinical trials [26] and considering the type I error
of 5% (a ¼ 0.05), type II error of 20% (b ¼ 0.2; Power ¼ 80%), and serum hs-CRP
level as a key variable, we reached the sample size of 16 women for each group.
Pregnant women ages 18 to 40 y diagnosed with GDM by a 100-g oral glucose
tolerance test at 24 to 28 wk gestation were recruited. Gestational age was
assessed from the date of last menstrual period and concurrent clinical assessment
[28]. Pregnant women without a previous diagnosis of glucose intolerance
were screened for GDM by two procedures. First, a 50 g glucose challenge test
was used as preliminary screening. Individuals with 1-h plasma glucose
concentrations of > 140 mg/dL were then asked to participate in a 100 g oral
glucose tolerance test. Diagnosis of GDM was done based on the criteria
of American Diabetes Association [29]. Women with two of the following criteria
were considered as having GDM: fasting plasma glucose (FPG) > 95 mg/dL, 1-h
plasma glucose 180 mg/dL, 2-h plasma glucose 155 mg/dL, and 3-h plasma
glucose 140 mg/dL. Forty-five women attending maternity clinics affiliated
with Kashan University of Medical Sciences were screened for GDM. Of these, 40
met the inclusion criteria (pregnant women ages 18–40 y at 24–28 wk gestation,
no previous history of GDM, non-smoker, having GDM based on previously
m