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

September 21, 2021 updated by: Harald Mangge, MD, Medical University of Graz

Study for the Investigation of New Individual Risk Profiles and Therapeutic Strategies in Obesity Related Cardiovascular and Metabolic Disorders.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 obesity associated pathologic conditions 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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Clinical Institute for Medical and Chemical Laboratory Diagnosis
        • Contact:
        • Principal Investigator:
          • Harald Mangge, Prof., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • thyroid dysfunction, infections, chronic diseases (e.g. autoimmune, inflammatory), neoplasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • lifestyle counseling
Interventional branch
A lifestyle intervention following a holistic schedule was done in a subgroup of obese juveniles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Technical University of Munich
Paracelsus Medical University
University of Graz
Graz University of Technology
Zukunftsfonds Steiermark
Bundesministerium für Gesundheit, Familie und Jugend
Steiermärkische Landesregierung

Investigators

  • Principal Investigator: Harald Mangge, Prof., MD, Medical University of Graz, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 5, 2007

First Posted (ESTIMATE)

June 6, 2007

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2720000021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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