NCT03394313

Brief Summary

Type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) are closely related. T2DM risk equivalent for CVD and it remains the major cause of death in T2DM. Thus, patients with T2DM and CVD disease are at very high-risk of CVD-related mortality. Therefore, more aggressive metabolic and hemodynamic control is required in such patients to improve the prognosis. We recently initiated a cardio-metabolic clinical service at the Heart Hospital, where T2DM patients with existing CVD are simultaneously examined by Cardiologist and Diabetologist for optimal metabolic and hemodynamic control. We would like to start a clinical registry for all patients who attend this clinical service to collect import clinical data about this population. This registry will serve an important source for future clinical research in the field.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2017Dec 2027

Study Start

First participant enrolled

September 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 9, 2018

Status Verified

December 1, 2017

Enrollment Period

10.3 years

First QC Date

January 1, 2018

Last Update Submit

January 7, 2018

Conditions

Keywords

Registry

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Ten years (15/09/2017 to 31/12/2027)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 2 diabetes mellitus and cardiovascular disease

You may qualify if:

  • Patients with type 2 diabetes mellitus
  • Newly diagnosed heart disease, such as ischemic heart disease, heart failure.

You may not qualify if:

  • Patients who do not have type 2 diabetes mellitus
  • Preexisting heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Coorporation

Doha, 3050, Qatar

RECRUITING

Related Publications (4)

  • Siscovick DS, Sotoodehnia N, Rea TD, Raghunathan TE, Jouven X, Lemaitre RN. Type 2 diabetes mellitus and the risk of sudden cardiac arrest in the community. Rev Endocr Metab Disord. 2010 Mar;11(1):53-9. doi: 10.1007/s11154-010-9133-5.

    PMID: 20195771BACKGROUND
  • Kucharska-Newton AM, Couper DJ, Pankow JS, Prineas RJ, Rea TD, Sotoodehnia N, Chakravarti A, Folsom AR, Siscovick DS, Rosamond WD. Diabetes and the risk of sudden cardiac death, the Atherosclerosis Risk in Communities study. Acta Diabetol. 2010 Dec;47 Suppl 1(Suppl 1):161-8. doi: 10.1007/s00592-009-0157-9. Epub 2009 Oct 24.

    PMID: 19855920BACKGROUND
  • Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.

    PMID: 25126392BACKGROUND
  • Shah AD, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015 Feb;3(2):105-13. doi: 10.1016/S2213-8587(14)70219-0. Epub 2014 Nov 11.

    PMID: 25466521BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jassim Al-Suwaidi, MD

    Hamad Medical Coorporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jassim Al-Suwaidi, MD

CONTACT

Rajvir Singh, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 9, 2018

Study Start

September 15, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 9, 2018

Record last verified: 2017-12

Locations