Relation of Visceral Fat and Associated Cytokines With Early Cardiovascular Complications in Type 1 Diabetes.

NCT02689570 | Unknown

• 1 other identifier: VISCERA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To investigate whether visceral adipose tissue (VAT) and its adipokines contribute to early signs of cardiovascular disease, meaning coronary artery calcifications (CAC) and diastolic dysfunction in type 1 diabetes (T1DM). Research Design \& Methods: A cross-sectional study of T1DM patients without a history of cardiovascular disease. CAC and VAT are measured using a CT scan. CAC is scored using the Agatston method. Echocardiography is performed to assess contractile abnormalities. Serum levels of adipocytokines (adiponectin, leptin, IL-6 and TNF-a) are measured using ELISA assays.

Conditions

Type 1 Diabetes; Coronary Artery Calcifications; Diastolic Dysfunction

Keywords

type 1 diabetes; coronary artery calcifications; diastolic dysfunction; adipokines; visceral adipose tissue

Outcome Measures

Primary Outcomes (1)

• coronary artery calcifications

  A 64-slice non-contrast multidetector CT scan of the coronary arteries was performed to measure coronary artery calcifications (CAC) (Lightspeed, VCT; General Electric Medical Systems, Waukesha, Wis, Milwaukee, USA). Scoring was done by one skilled radiologist (R. Salgado), who was blinded to the subjects case files. Typical imaging parameters were: tube voltage 100 kv; current intensity 310 mA; rotation time 500 ms; and detector collimation 64 x 0.625 mm. Scan data were reconstructed at 75% of the cardiac cycle after the QRS complex. The radiation dose for calcium scoring ranged at 1.3-1.7 mSv. CAC was quantified (Agatston score) by means of a dedicated software application (SmartScore, AW). The Agatston score is the product of CAC area times the density.

  once at the moment of inclusion of this cross-sectional, observational study

Secondary Outcomes (1)

• diastolic dysfunction

  once at the moment of inclusion of this cross-sectional, observational study

Study Arms (1)

type 1 diabetic patients

Adult T1DM patients, aged 18-75 years, regularly attending the out-patient diabetes clinic of the Antwerp University Hospital are recruited starting from June 2011. Patients had to have a diabetes duration of ≥5 years and be in general good health to be included. Exclusion criteria were a history of a major adverse cardiovascular event (myocardial infarction, stroke), other cardiovascular complaints, pregnancy or a glomerular filtration rate ≤30 ml/min/1.73 m2.

Other: observational

Interventions

observational OTHER

no interventions; observational study

Also known as: no interventions; observational study

type 1 diabetic patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult type 1 diabetic patients regularly attending the out-patient diabetes clinic of the Antwerp University Hospital

You may qualify if:

• type 1 diabetic patients (criteria for diagnosis by the American Diabetes Association
• diabetes duration ≥5 years
• general good health

You may not qualify if:

• having experienced a major adverse cardiovascular event (myocardial infarction,stroke)
• having cardiovascular complaints
• pregnancy
• having an estimated glomerular filtration ≤ 30ml/min/1.73 m²

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

Related Publications (1)

• De Block CEM, Shivalkar B, Goovaerts W, Brits T, Carpentier K, Verrijken A, Van Hoof V, Parizel PM, Vrints C, Van Gaal LF. Coronary artery calcifications and diastolic dysfunction versus visceral fat area in type 1 diabetes: VISCERA study. J Diabetes Complications. 2018 Mar;32(3):271-278. doi: 10.1016/j.jdiacomp.2017.11.008. Epub 2017 Nov 28.

  PMID: 29310998 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA sample

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Watchful Waiting; Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques

Study Officials

• Luc F Van Gaal, MD, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe EM De Block, MD, PhD

CONTACT

+3238214364; christophe.deblock@uza.be

Luc F Van Gaal, MD, PhD

CONTACT

+328213278; luc.vangaal@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 24, 2016
• Study Start: June 1, 2011
• Primary Completion: January 1, 2017
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)