Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

• Conditions: Diabetes Mellitus

• Registration Number: NCT02542774
• Lead Sponsor: University College, London

Brief Summary

To evaluate the risk of cardiovascular events associated with medication use for controlling blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated in primary care

Detailed Description

The management and treatment of adult diabetes is far from optimal. The most recent report from the National Diabetes Audit showed that only one in three people with diabetes are achieving recommended standards for controlling blood glucose, blood pressure and cholesterol levels; and only three in five received basic care processes to reduce their risk of diabetes-related complications such as blindness, amputation and kidney disease. Women did 15% worse than men, which may explain some of the reported higher excess risk of coronary heart disease and stroke, consequent to diabetes in women than men. More efficient and equitable care in people with diabetes could lead to substantial cost savings, and would improve the lives of women and men currently living with diabetes.

The objective of this research isto evaluate the risk of cardiovascular events associated with medication use for controlling blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated in primary care.

Study Timeline

• Study Start: 2015-08
• Status Verified: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-03
• Last Update Submitted: 2015-09-03
• Study First Posted: 2015-09-07
• Last Update Posted: 2015-09-07
• Primary Completion: 2015-10
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

• Patients with diabetes at or before study entry, and participants who develop new-onset diabetes during follow-up.
• Age ≥ 18 years
• Data collected in the period 1997-2010
• Minimum time since registration of 1 year
• Minimum of 1 year of up to standard data (CPRD quality standard)

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First occurrence of cardiovascular disease	10 years	First recorded diagnosis of cardiovascular disease during follow-up: stable angina, unstable angina, myocardial infarction, unheralded coronary death, heart failure, transient ischaemic attack, ischaemic stroke, subarachnoid haemorrhage, intracerebral haemorrhage, peripheral arterial disease, abdominal aortic aneurysm, ventricular arrhythmia, cardiac arrest, or sudden cardiac death

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	10 years	Composite endpoint of cardiovascular mortality
All cause mortality	10 years	Composite endpoint of all cause mortality

Trial Locations

Locations (1)

The George Institute for Global Health, Nuffield Department for Population Health, University of Oxford; 🇬🇧 Oxford, United Kingdom