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

This study is currently recruiting participants.
Verified June 2013 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: June 3, 2013
Last verified: June 2013
  Purpose

To improve the understanding of the pathophysiology of body weight and lifestyle extremes and to work against the increasing burden of obesity and associated pathologic consequences, 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, 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 related individual high risk profiles for cardiovascular/metabolic disease in juveniles, young, and middle-aged adults between 0 and 65 years. Based on this information, new and effective strategies are developed for prevention and early intervention. Concerning mechanisms of obesity associated pathologic conditions, the individual adipose tissue topography, disturbed adipokine balance, brown and white adipose tissue (BAT/WAT) function, craving like behaviour, chronic immune-mediated inflammation, genetic/epigenetics (eg. role of miRNAs), 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.

Since 2011, the investigative spectrum of STYJOBS / EDECTA is additionally extended to 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

Detailed Description:

Obesity is dramatically increasing in the so called western world and newly also in Asia, whereby juveniles are affected in particular. Atherosclerosis, a major consequence of obesity, starts early in life and results in cardiovascular disease and stroke, the main causes of mortality in industrialized countries. STYJOBS / EDECTA is a prospective, observational study to improve the understanding of atherosclerosis and metabolic changes in obesity by investigation of the "non-biased" early phase.

AIMS

  • Identification of "individual metabolic high risk patterns" in obesity by linking lab parameters (adipokines, immune-inflammatory mediators, oxidative "stress" biomarkers, lipoproteins, molecular genetics, epigenetics), individual adipose tissue topography, early vascular changes (carotis intima media thickness by sonography), life style habits, sport performance diagnostics, and clinical data. STYJOBS/EDECTA-Databank.
  • Evaluation and development of an early intervention by a holistic strategy (i.e. Lipometer adjusted Sport Program, Nutritional Device, Behavioral Therapy). STYJOBS-Intervention.
  • To establish a comprehensive serum/plasma/DNA resource of young, adolescent, and middle aged obese probands, their parents, and normal weight age matched controls for advanced research (e.g. molecular genetics, epigenetics, microRNAs) in obesity. STYJOBS/EDECTA-Biobank.
  • To improve the understanding of craving in obesity (e.g.link insulin resistance - control of hedonic inputs).
  • EDECTA (Early DEteCTion of Atherosclerosis) extends the STYJOBS Database and Bioresource with normal weight and obese probands aged up to 65 years.

Thus, STYJOBS / EDECTA comprehends data and biomaterial of the preclinical phase of major sequels of obesity such as type 2 diabetes, myocardial infarction, stroke and cancer. An essential part of the identification of novel individual risk profiles is given by the combined analysis of clinical, anthropometric data, biomarkers(e.g. adipokines, oxidative/nitrosative "stress" markers, inflammatory cytokines), BAT/WAT balance, genetics, and epigenetics(e.g. microRNAs). This approach is performed in collaboration with the Graz University of Technology, Institute for Genomics and Bioinformatics (Operator, Marcel Scheideler, PhD). To further improve the understanding of dysbalanced energy expenditure in obesity mitochondrial haplotypes are investigated in cooperation with Dr.Weghuber, Dr.Eder and Prof.Sperl from the Salzburg Paracelsus Private Medical School. All genetic and epigenetic measurements are performed by an anonymous approach (data privacy protection) after careful accreditation by the local ethical committee.

The investigative spectrum of STYJOBS / EDECTA is also extended to underweight/anorectic people. This condition is an attractive biologic "counterpart" to the overweight/obese group. Extremely underweight and anorectic patients are afflicted with profound metabolic abnormalities. Thus, it is interesting to investigate anorexia associated risk profiles in comparison to those found in overweight/obese people. Especially the craving like behaviour and the cardiovascular/"ox"Stress risk will be focused in our investigations.

Finally, we started to investigate the role of tryptophan (TRP) metabolism in context with obesity, immune-mediated inflammation, and mechanisms underlying uncontrolled overeating.

  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
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: June 3, 2013
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:
Fatty Liver
Insulin Resistance
Liver Diseases
Obesity
Digestive System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013