Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes: an Examination of Variation in Health Service Delivery

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: No intervention is given.

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 Type: Observational
• Enrollment (Anticipated): 80000

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX1 3BD
    • The George Institute for Global Health, Nuffield Department for Population Health, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the CALIBER database who have diabetes, are included in the Clinical Practice Research Datalink (CPRD) and consented to data linkage.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First occurrence of cardiovascular disease	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	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	Composite endpoint of cardiovascular mortality	10 years
All cause mortality	Composite endpoint of all cause mortality	10 years

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Study Director: Sanne Peters, The George Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Stroke; Heart failure; Myocardial infarction; Stable angina pectoris; Diabetes mellitus; Quality of care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: 15_108R