Trial record 2 of 79 for:    leptin and type 1 diabetes

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University Hospital, Antwerp
Universiteit Antwerpen
Information provided by (Responsible Party):
Christophe De Block, University Hospital, Antwerp Identifier:
First received: February 11, 2016
Last updated: February 18, 2016
Last verified: February 2016

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.

Condition Intervention
Type 1 Diabetes
Coronary Artery Calcifications
Diastolic Dysfunction
Other: observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Relation of Visceral Fat and Associated Cytokines With Early Cardiovascular Complications in Type 1 Diabetes: the VISCERA Study

Resource links provided by NLM:

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • coronary artery calcifications [ Time Frame: once at the moment of inclusion of this cross-sectional, observational study ]
    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.

Secondary Outcome Measures:
  • diastolic dysfunction [ Time Frame: once at the moment of inclusion of this cross-sectional, observational study ]
    Standard 2-dimensional and Doppler Echocardiography (iE-33 Philips, The Netherlands) was performed by a single cardiologist blinded to the clinical status of the study participants. Briefly, left ventricular function was assessed by the parasternal long axis M-mode and modified biplane Simpson method. Diastolic function was determined taking into account all the following parameters: mitral inflow, pulmonary vein inflow signal and mitral annular tissue Doppler (tD) velocities from end expiratory cycles

Biospecimen Retention:   Samples With DNA
EDTA sample

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
no interventions; observational study
Other Name: no interventions; observational study

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult type 1 diabetic patients regularly attending the out-patient diabetes clinic of the Antwerp University Hospital

Inclusion Criteria:

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

Exclusion Criteria:

  • having experienced a major adverse cardiovascular event (myocardial infarction,stroke)
  • having cardiovascular complaints
  • pregnancy
  • having an estimated glomerular filtration ≤ 30ml/min/1.73 m²
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02689570

Contact: Christophe EM De Block, MD, PhD +3238214364
Contact: Luc F Van Gaal, MD, PhD +328213278

Antwerp University Hospital Recruiting
Edegem, Belgium, 2650
Contact: Christophe De Block, MD PhD    +3238214364   
Contact: Luc Van Gaal, MD PhD         
Principal Investigator: Christophe De Block, MD PhD         
Principal Investigator: Luc Van Gaal, MD PhD         
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Principal Investigator: Luc F Van Gaal, MD, PhD Universiteit Antwerpen
  More Information

Responsible Party: Christophe De Block, MD PhD, University Hospital, Antwerp Identifier: NCT02689570     History of Changes
Other Study ID Numbers: VISCERA 
Study First Received: February 11, 2016
Last Updated: February 18, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University Hospital, Antwerp:
type 1 diabetes
coronary artery calcifications
diastolic dysfunction
visceral adipose tissue

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Calcium Metabolism Disorders
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases processed this record on January 19, 2017