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Observational Study of Early Metabolic and Vascular Changes in Obesity (STYJOBS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Graz
Sponsor:
Collaborators:
Zukunftsfond Steiermark
Bundesministerium für Gesundheit, Familie und Jugend
Steiermärkische Landesregierung
Graz University of Technology
University of Graz
Paracelsus Medical University
Technische Universität München
Information provided by (Responsible Party):
Harald Mangge, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00482924
First received: June 4, 2007
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

To work against the increasing burden of obesity, the STYJOBS / EDECTA (STYrian Juvenile OBesity Study / Early DetECtion of Atherosclerosis) project was started at the Medical University of Graz in 2003. STYJOBS / EDECTA is a prospective, observational study to improve the understanding of atherosclerosis, cardiovascular risk, immune mediated low grade inflammation, and metabolic changes in obesity by investigation of the "non-biased" early phase.

The main focus is the early identification of obesity and "worse lifestyle" related individual high risk profiles for cardiovascular/metabolic/immune-inflammatory disease in juvenile, young, and adult persons up to the age of 65 years. Based on this information, new and effective strategies are developed for preclinical diagnostics and early intervention. Concerning mechanisms of obesity and "bad" lifestyle associated pathologic conditions, risk biomarker patterns, chronic immune-mediated inflammation, disturbed adipokine balance, individual adipose tissue topography, brown and white adipose tissue (BAT/WAT) function, addiction like behaviour, genetics/epigenetics (eg. role of miRNAs), early vascular pathology, and fatty liver disease are in focus of research. The interventional program consists of a holistic strategy comprehending sports, and lifestyle modification. An improved basic understanding of the role of a disturbed energy expenditure in the etiology of obesity should give the basis for new paradigms in therapy of obesity.

The investigative spectrum of STYJOBS / EDECTA was extended also to non-obese body weight extremes i.e. underweight/anorectic people.


Condition Intervention
Understanding of Early Settings to an Obesity "Career"
Vascular Burden in Obesity
Brown/White Adipose Tissue
Adipokines
Fatty Liver Disease
Insulin Resistance
Other: Lifestyle modification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study for the Investigation of New Individual Risk Profiles and Therapeutic Strategies in Obesity Related Cardiovascular and Metabolic Disorders.

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obesity related biomarkers (fasting glucose, insulin, HOMA-index, HbA1c, liver transaminases, inflammatory markers, adipokines, clotting parameters, lipids, oxidative stress markers, Biomarkers related to tryptophan metabolism), performance diagnostics. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Collection of fasted blood samples between 9 and 12 AM.


Estimated Enrollment: 1500
Study Start Date: January 2003
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Overweight/obese

The cohort consists of age and sex matched normal weighted controls and overweight/obese persons.

Definition for "overweight": BMI >90th and <97th percentile, if under 18 years of age, and BMI >25 and <29.9 kg/m2 if over 18 years of age.

Definition for "obese": BMI >97th percentile, if under 18 years of age, and BMI >30kg/m2, if over 18 years of age.

Other: Lifestyle modification
Regular sports and dietary advices. Controlled by analysis of laboratory parameters, BMI change and performance diagnostics. No drugs included so far.
Other Name: lifestyle counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Probands are residents of Graz and from the federal state of styria.

Criteria

Inclusion Criteria:

  • general healthy condition except overweightness/obesity, age below 55 years

Exclusion Criteria:

  • thyroid dysfunction, infections, chronic diseases (e.g. autoimmune, inflammatory), neoplasia
  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 ClinicalTrials.gov identifier: NCT00482924

Contacts
Contact: Harald Mangge, Prof., MD +43 316 385 ext 83340 harald.mangge@klinikum-graz.at

Locations
Austria
Clinical Institute for Medical and Chemical Laboratory Diagnosis Recruiting
Graz, Styria, Austria, 8036
Contact: Harald Mangge, Prof., MD    +43316 385 ext 83340    harald.mangge@klinikum-graz.at   
Principal Investigator: Harald Mangge, Prof., MD         
Sponsors and Collaborators
Medical University of Graz
Zukunftsfond Steiermark
Bundesministerium für Gesundheit, Familie und Jugend
Steiermärkische Landesregierung
Graz University of Technology
University of Graz
Paracelsus Medical University
Technische Universität München
Investigators
Principal Investigator: Harald Mangge, Prof., MD Medical University of Graz, Austria
  More Information

Additional Information:
Publications:

Responsible Party: Harald Mangge, MD, Professor Dr.med., Medical University of Graz
ClinicalTrials.gov Identifier: NCT00482924     History of Changes
Other Study ID Numbers: A2720000021
Study First Received: June 4, 2007
Last Updated: January 7, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
obesity
cardiovascular risk profiles
adipokines
preatherosclerosis
low grade inflammation
dyslipidemia
insulin resistance
brown adipose tissue
white adipose tissue

Additional relevant MeSH terms:
Obesity
Fatty Liver
Insulin Resistance
Liver Diseases
Body Weight
Digestive System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014