Observational Study of Early Metabolic and Vascular Changes in Obesity (STYJOBS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
Probands are residents of Graz and from the federal state of styria.
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| Contact: Harald Mangge, Prof., MD | +43 316 385 ext 83340 | harald.mangge@klinikum-graz.at |
| 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 | |
| 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