Carotid Atherosclerosis and Vascular Events in People With Diabetes

NCT02929355 | Completed

• 1 other identifier: 69HCL16_0596
• Study Type: observational
• Target: 731
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.

Conditions

Carotid Atherosclerosis

Keywords

Carotid atherosclerosis; duplex ultrasonography; diabetes; vascular events

Outcome Measures

Primary Outcomes (1)

• Rate of vascular events between day one and the last day of follow-up reviewed by patient examination

  Vascular events include ischemic myocardial events, ischemic cerebrovascular events, lower limb ischemia, arterial revascularization procedure

  Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)

Secondary Outcomes (1)

• Rate of carotid atherosclerosis progression measured by duplex ultrasonography in percentage of stenosis

  Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016.

Study Arms (1)

diabetic patients with carotid assessment

Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit

Other: carotid assesment by duplex ultrasonography

Interventions

carotid assesment by duplex ultrasonography OTHER

diabetic patients with carotid assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit

You may qualify if:

• Age \>18 ans
• Diabetes
• Carotid duplex ultrasonography in 2012

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location

Related Publications (1)

• Vouillarmet J, Marsot C, Maucort-Boulch D, Riche B, Helfre M, Grange C. Vascular Events and Carotid Atherosclerosis: A 5-Year Prospective Cohort Study in Patients with Type 2 Diabetes and a Contemporary Cardiovascular Prevention Treatment. J Diabetes Res. 2019 Dec 22;2019:9059761. doi: 10.1155/2019/9059761. eCollection 2019.

  PMID: 31934592 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 11, 2016
• Study Start: January 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-09

Locations

FR (1)