Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

September 3, 2015 updated by: University College, London

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Study Director: Sanne Peters, The George Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15_108R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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