CClinicalTrials.gg
Status unknownNCT02542774Updated Sep 7, 2015

Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

An observational study in Diabetes Mellitus, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-07.

Sponsored by University College, London · Observational

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80,000
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • Diabetes mellitus
  • Stroke
  • Myocardial infarction
  • Stable angina pectoris
  • Heart failure
  • Quality of care
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 80,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80,000 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention is given.

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

06

What researchers measure

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

    Time frame: 10 years

Secondary outcomes

  1. Cardiovascular mortality

    Composite endpoint of cardiovascular mortality

    Time frame: 10 years

  2. All cause mortality

    Composite endpoint of all cause mortality

    Time frame: 10 years

07

Study locations

1 site
  • The George Institute for Global Health, Nuffield Department for Population Health, University of Oxford
    Oxford, OX1 3BD, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02542774
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Sep 7, 2015
Start date
Aug 2015
Primary completion
Oct 2015 (estimated)
Completion
Nov 2016 (estimated)
Last update
Sep 7, 2015

Study contacts

Sanne Peters
study director · The George Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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