Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02542774
• Other study ID #: 15_108R
• Status: Active, not recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 3, 2015
• Start date: August 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80000
• Est. completion date: November 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus

Intervention

Other:
• No intervention is given.
This study is based on the analysis of linked electronic health records (CALIBER dataset)

Locations

Country	Name	City	State
United Kingdom	The George Institute for Global Health, Nuffield Department for Population Health, University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cardiovascular mortality	Composite endpoint of cardiovascular mortality	10 years	No
Secondary	All cause mortality	Composite endpoint of all cause mortality	10 years	No