Observational Study of Early Metabolic and Vascular Changes in Obesity — STYJOBS  

Obesity Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adiponectin Deficiency
• Atherosclerosis
• Fatty Liver
• Inflammation
• Obesity

• NCT number: NCT00482924
• Study type: Observational
• Source: Medical University of Graz
• Contact: Harald Mangge, Prof., MD
• Phone: +43 316 385
• Email: harald.mangge@klinikum-graz.at
• Status: Recruiting
• Start date: January 2003
• Completion date: December 2022