Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

NCT02542774 | Unknown DMC

• 1 other identifier: 15_108R
• Study Type: observational
• Target: 80,000
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; Stroke; Myocardial infarction; Stable angina pectoris; Heart failure; Quality of care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cardiovascular mortality

  10 years

• All cause mortality

  10 years

Interventions

No intervention is given. OTHER

This study is based on the analysis of linked electronic health records (CALIBER dataset)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

The George Institute for Global Health, Nuffield Department for Population Health, University of Oxford

Oxford, Oxford, OX1 3BD, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Stroke; Myocardial Infarction; Angina, Stable; Heart Failure

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sanne Peters

  The George Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2016
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

GB (1)