Polycystic ovary syndrome (PCOS) is one of the common conditions affecting women in their reproductive age. In the case of PCOS, the ovaries create abnormally high levels of male sex hormones that are typically present in women in trace amounts. Menstrual cycle irregularities, polycystic ovaries, excess hair on face and body and acne are typical symptoms.
Women with PCOS can produce insulin but their bodies are unable to use it efficiently, raising their risk of developing type 2 diabetes. As a result PCOS has been linked to type 2 diabetes, which may later lead to microvascular complications.
Our aim is to investigate the association between PCOS and microvascular complications among women with type 2 diabetes. Using the primary care database CPRD Aurum, patients with a diagnosis of type 2 diabetes will be captured. Of these patients, women with a diagnosis of PCOS and without PCOS will be selected, wherein they are similar in terms of age, sex and BMI. After that, the number and proportion of the exposed (patients with PCOS) and unexposed (patients without PCOS) who have developed microvascular complications within the study period will be calculated. The association between PCOS and microvascular complications will be estimated after accounting for differences in age, BMI, ethnicity, deprivation, and other disease conditions at baseline.
This study is likely to benefit women with PCOS by establishing if they are at a higher risk for diabetes complications, so as to aid early detection, prevention and intervention.
Among women with PCOS, the presentation of hyperandrogenism leads to insulin resistance, therefore PCOS is often associated with type 2 diabetes, its complications and other cardiovascular diseases.
The objective of the study is to investigate whether PCOS is a risk factor for microvascular complications among women with type 2 diabetes. In this study the objectives are to estimate the incidence of microvascular complication among women with type 2 diabetes and PCOS; women with type 2 diabetes and without PCOS and the relative difference in the incidence of microvascular complications among women with PCOS compared to women without PCOS.
A retrospective cohort study will be conducted from 01 Jan 2000 to 31st December 2020. Participants will be selected from CPRD AURUM primary care database. All patients with a type 2 diabetes diagnosis will be eligible for inclusion in the study. Patients with a pre-existing diagnosis of PCOS prior to type 2 diabetes diagnosis will form the exposed cohort and the unexposed patient cohort will be randomly selected from a pool of patients without PCOS after matching for age, sex, body mass index, and type 2 diabetes duration.
The primary outcome to be measured is composite microvascular complications. The secondary outcome to be measured is each microvascular complication: (1) diabetic retinopathy, (2) diabetic neuropathy, (3) diabetic nephropathy and (4) diabetic foot disease.
The primary analysis, a Cox proportional hazard model will be used to estimate the adjusted hazard ratio for the outcomes among patients with PCOS compared to patients without PCOS. Adjustment will be made for pre-defined cofounders such as age, sex, BMI, ethnicity, deprivation (obtained from linked Index of Multiple Deprivation data), and other comorbidities at baseline.
This study is likely to benefit patients by stratifying those at a higher risk for diabetes complications for potential early detection.
The primary outcome to be measured is composite microvascular complications.
The secondary outcome to be measured is each microvascular complication:
(1) diabetic retinopathy,
(2) diabetic neuropathy,
(3) diabetic nephropathy and
(4) diabetic foot disease.
Anuradhaa Subramanian - Chief Investigator - University of Birmingham
Anuradhaa Subramanian - Corresponding Applicant - University of Birmingham
Divya Singh - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Patient Level Index of Multiple Deprivation