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

This study is currently recruiting participants.
Verified September 2017 by Harald Mangge, MD, Medical University of Graz
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482924
First Posted: June 6, 2007
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Zukunftsfonds 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
  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, metabolic changes, and general disease propensity in obesity. The investigation of the "non-biased" early phase is strongly focused.

Based on this information, new and effective strategies for preclinical diagnostics and early intervention are of main interest. We seek a better understanding of critical lipid profiles, chronic immune-mediated inflammation, disturbed adipokine balance, critical adipose tissue topography, addiction like behaviour, genetics/epigenetics, early vascular pathology, and fatty liver disease. Interventional branches of study tested a holistic strategy comprehending sports, and lifestyle modification for efficiency. The investigative spectrum of STYJOBS / EDECTA comprehends also non-obese body weight extremes i.e. underweight/anorectic people.


Condition Intervention
Obesity Atherosclerosis Inflammation Adiponectin Deficiency Fatty Liver Other: Lifestyle intervention

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 Harald Mangge, MD, Medical University of Graz:

Primary Outcome Measures:
  • Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention [ Time Frame: 12 months ]

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 ]

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 2019
Estimated Primary Completion Date: December 2018 (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 intervention
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
Interventional branch
A lifestyle intervention following a holistic schedule was done in a subgroup of obese juveniles.

Detailed Description:

Obesity is dramatically increasing in countries with so called western Lifestyle, 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.

We aim

To identify "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 damage, life style habits, and clinical data.

The STYJOBS/EDECTA-Database comprehends currently data from 1325 subjects.For each proband 282 variables are available (Clinical, anthropometric, carotis IMT, 82; Laboratory/Biomarkers, 100; Glucose metabolism, liver, kidney function, lipids, oxidative/nitrosative stress, adipokines, gut-brain axis, clotting, Genetic/mitochondrial function/miscellaneous,100), and the results of an early interventional trial by a holistic strategy.

To establish a comprehensive biobank. The STYJOBS/EDECTA-biomaterial resource comprises serum/plasma/DNA left over probes from currently 1256 probands.

EDECTA (Early DEteCTion of Atherosclerosis) extends the STYJOBS Database and Bioresource with normal weight and obese probands aged up to 80 years.

To improve the understanding of craving and addiction like behaviour in obesity (e.g.link insulin resistance - control of hedonic inputs).

Thus, the STYJOBS / EDECTA resource comprises in extendo data and biomaterial specimen from subjects afflicted with the preclinical phase of major sequels of obesity such as insulin resistance, cardiovascular disease, and probably also certain sorts of cancer.

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.

Further, we investigate the role of tryptophan (TRP) metabolism in context with obesity, immune-mediated inflammation, skewing of T helper cells and mechanisms underlying uncontrolled overeating.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Zukunftsfonds 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

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
First Submitted: June 4, 2007
First Posted: June 6, 2007
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Harald Mangge, MD, 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
Inflammation
Atherosclerosis
Fatty Liver
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases