Materials and Methods: A cross-sectional study was conducted at Hospital Universiti Sains Malaysia (Hospital USM), Health Campus, Kubang Kerian, Kelantan, Malaysia. Thirty newly diagnosed patients with PCOS attending gynecology clinic between July 2016 and April 2017 were recruited. Fasting venous blood samples were collected from the subjects. Serum AMH, insulin, adiponectin, triglycerides, high-density lipoprotein cholesterol (HDL-C), and plasma glucose levels were measured, and insulin resistance was calculated based on homeostasis model of assessment-insulin resistance (HOMA-IR). The serum AMH level was estimated, and the correlation of serum AMH level with the metabolic parameters was analyzed.
Results: The median of serum AMH levels in women with PCOS was 6.8 ng/mL (interquartile range: 7.38 ng/mL). There was a significant negative correlation between serum AMH and HOMA-IR or triglyceride levels (r = -0.49, P = 0.006 and r = -0.55, P = 0.002, respectively). A significant positive correlation was observed between serum AMH and serum HDL-C or serum adiponectin levels (r = 0.56, P = 0.001 and r = 0.44, P = 0.014, respectively) in all study subjects.
Conclusion: The serum AMH level is associated with HOMA-IR, triglycerides, HDL-C, and adiponectin levels, and hence it may be used as a potential cardiometabolic risk marker in women with PCOS.
METHODS: DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.
RESULTS: Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose.
CONCLUSION: These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.
TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.