ObesitySTYJOBSNCT00482924
Observational Study of Early Metabolic and Vascular Changes in Obesity
An observational study of Obesity and Atherosclerosis, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 3 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Atherosclerosis, Inflammation
- What is being tested?
- Lifestyle intervention
- How many people
- 1,500 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2003to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Probands are residents of Graz and from the federal state of styria.
Who may be able to join
- general healthy condition except overweightness/obesity, age below 55 years
Who cannot join
- thyroid dysfunction, infections, chronic diseases (e.g. autoimmune, inflammatory), neoplasia
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Clinical Institute for Medical and Chemical Laboratory Diagnosis
Graz, Styria, 8036
Harald Mangge, Prof., MD, +43316 385 ext. 83340, harald.mangge@klinikum-graz.at
Harald Mangge, Prof., MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Atherosclerosis, Inflammation, Adiponectin Deficiency, Fatty Liver
- Being tested
- Lifestyle intervention
- Keywords
- obesity, cardiovascular risk profiles, adipokines, preatherosclerosis, low grade inflammation, dyslipidemia, insulin resistance, brown adipose tissue, white adipose tissue
- Medical subject headings
- Obesity, Atherosclerosis, Inflammation, Hypoadiponectinemia, Fatty Liver, Dyslipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionOther
Also called lifestyle counseling
Regular sports and dietary advices. Controlled by analysis of laboratory parameters, BMI change and performance diagnostics. No drugs included so far.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lifestyle intervention | |
| Interventional branch | A lifestyle intervention following a holistic schedule was done in a subgroup of obese juveniles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startJan 2003
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Zukunftsfonds Steiermark, Bundesministerium für Gesundheit, Familie und Jugend, Steiermärkische Landesregierung, Graz University of Technology, University of Graz, Paracelsus Medical University, Technical University of Munich
- Responsible party
- Principal investigator, Harald Mangge, MD, Medical University of Graz
- Investigators
- Harald Mangge, Prof., MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482924
- Sponsor's protocol ID
- A2720000021
- Acronym
- STYJOBS
- Status last verified
- Sep 2021
- First submitted
- 4 Jun 2007
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pilz S, Mangge H, Wellnitz B, Seelhorst U, Winkelmann BR, Tiran B, Boehm BO, Marz W. Adiponectin and mortality in patients undergoing coronary angiography. J Clin Endocrinol Metab. 2006 Nov;91(11):4277-86. doi: 10.1210/jc.2006-0836. Epub 2006 Aug 15.
PubMed 16912132Murr C, Winklhofer-Roob BM, Schroecksnadel K, Maritschnegg M, Mangge H, Bohm BO, Winkelmann BR, Marz W, Fuchs D. Inverse association between serum concentrations of neopterin and antioxidants in patients with and without angiographic coronary artery disease. Atherosclerosis. 2009 Feb;202(2):543-9. doi: 10.1016/j.atherosclerosis.2008.04.047. Epub 2008 May 15.
PubMed 18556000Pachler C, Ikeoka D, Plank J, Weinhandl H, Suppan M, Mader JK, Bodenlenz M, Regittnig W, Mangge H, Pieber TR, Ellmerer M. Subcutaneous adipose tissue exerts proinflammatory cytokines after minimal trauma in humans. Am J Physiol Endocrinol Metab. 2007 Sep;293(3):E690-6. doi: 10.1152/ajpendo.00034.2007. Epub 2007 Jun 19.
PubMed 17578890Pilz S, Mangge H, Obermayer-Pietsch B, Marz W. Visfatin/pre-B-cell colony-enhancing factor: a protein with various suggested functions. J Endocrinol Invest. 2007 Feb;30(2):138-44. doi: 10.1007/BF03347412.
PubMed 17392604Arnold T, Brandlhofer S, Vrtikapa K, Stangl H, Hermann M, Zwiauer K, Mangge H, Karwautz A, Huemer J, Koller D, Schneider WJ, Strobl W. Effect of obesity on plasma clusterin, [corrected] a proposed modulator of leptin action. Pediatr Res. 2011 Mar;69(3):237-42. doi: 10.1203/PDR.0b013e31820930cb.
PubMed 21135756Fritsch P, Kleber M, Schlagenhauf A, Laschnik B, Fritsch M, Muntean W, Mangge H, Reinehr T. Normalization of haemostatic alterations in overweight children with weight loss due to lifestyle intervention. Atherosclerosis. 2011 May;216(1):170-3. doi: 10.1016/j.atherosclerosis.2011.01.042. Epub 2011 Feb 2.
PubMed 21334626Hasija R, Pistorio A, Ravelli A, Demirkaya E, Khubchandani R, Guseinova D, Malattia C, Canhao H, Harel L, Foell D, Wouters C, De Cunto C, Huemer C, Kimura Y, Mangge H, Minetti C, Nordal EB, Philippet P, Garozzo R, Martini A, Ruperto N; Pediatric Rheumatology International Trials Organization. Therapeutic approaches in the treatment of juvenile dermatomyositis in patients with recent-onset disease and in those experiencing disease flare: an international multicenter PRINTO study. Arthritis Rheum. 2011 Oct;63(10):3142-52. doi: 10.1002/art.30475.
PubMed 21647864Almer G, Wernig K, Saba-Lepek M, Haj-Yahya S, Rattenberger J, Wagner J, Gradauer K, Frascione D, Pabst G, Leitinger G, Mangge H, Zimmer A, Prassl R. Adiponectin-coated nanoparticles for enhanced imaging of atherosclerotic plaques. Int J Nanomedicine. 2011;6:1279-90. doi: 10.2147/IJN.S18739. Epub 2011 Jun 21.
PubMed 21753879Almer G, Saba-Lepek M, Haj-Yahya S, Rohde E, Strunk D, Frohlich E, Prassl R, Mangge H. Globular domain of adiponectin: promising target molecule for detection of atherosclerotic lesions. Biologics. 2011;5:95-105. doi: 10.2147/BTT.S22863. Epub 2011 Sep 7.
PubMed 22022204Landauer F, Huber G, Paulmichl K, O'Malley G, Mangge H, Weghuber D. Timely diagnosis of malalignment of the distal extremities is crucial in morbidly obese juveniles. Obes Facts. 2013;6(6):542-51. doi: 10.1159/000357280. Epub 2013 Dec 6.
PubMed 24335156Reininghaus EZ, McIntyre RS, Reininghaus B, Geisler S, Bengesser SA, Lackner N, Hecht K, Birner A, Kattnig F, Unterweger R, Kapfhammer HP, Zelzer S, Fuchs D, Mangge H. Tryptophan breakdown is increased in euthymic overweight individuals with bipolar disorder: a preliminary report. Bipolar Disord. 2014 Jun;16(4):432-40. doi: 10.1111/bdi.12166. Epub 2013 Dec 12.
PubMed 24330408Gradauer K, Barthelmes J, Vonach C, Almer G, Mangge H, Teubl B, Roblegg E, Dunnhaupt S, Frohlich E, Bernkop-Schnurch A, Prassl R. Liposomes coated with thiolated chitosan enhance oral peptide delivery to rats. J Control Release. 2013 Dec 28;172(3):872-8. doi: 10.1016/j.jconrel.2013.10.011. Epub 2013 Oct 16.
PubMed 24140721Bengesser SA, Lackner N, Birner A, Fellendorf FT, Platzer M, Mitteregger A, Unterweger R, Reininghaus B, Mangge H, Wallner-Liebmann SJ, Zelzer S, Fuchs D, McIntyre RS, Kapfhammer HP, Reininghaus EZ. Peripheral markers of oxidative stress and antioxidative defense in euthymia of bipolar disorder--Gender and obesity effects. J Affect Disord. 2015 Feb 1;172:367-74. doi: 10.1016/j.jad.2014.10.014. Epub 2014 Oct 22.
PubMed 25451439Lackner N, Mangge H, Reininghaus EZ, McIntyre RS, Bengesser SA, Birner A, Reininghaus B, Kapfhammer HP, Wallner-Liebmann SJ. Body fat distribution and associations with metabolic and clinical characteristics in bipolar individuals. Eur Arch Psychiatry Clin Neurosci. 2015 Jun;265(4):313-9. doi: 10.1007/s00406-014-0559-8. Epub 2014 Nov 8.
PubMed 25381166Mangge H, Becker K, Fuchs D, Gostner JM. Antioxidants, inflammation and cardiovascular disease. World J Cardiol. 2014 Jun 26;6(6):462-77. doi: 10.4330/wjc.v6.i6.462.
PubMed 24976919
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Investigation of New Individual Risk Profiles and Therapeutic Strategies in Obesity Related Cardiovascular and Metabolic Disorders.
- ClinicalTrials.gov ID
- NCT00482924
- Acronym / sponsor ID
- STYJOBS / A2720000021
- Conditions
- Obesity, Atherosclerosis, Inflammation, Adiponectin Deficiency, Fatty Liver
- Keywords
- obesity, cardiovascular risk profiles, adipokines, preatherosclerosis, low grade inflammation, dyslipidemia, insulin resistance, brown adipose tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Zukunftsfonds Steiermark, Bundesministerium für Gesundheit, Familie und Jugend, Steiermärkische Landesregierung, Graz University of Technology, University of Graz, Paracelsus Medical University, Technical University of Munich
- Study start
- Jan 2003
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight/obese | – | Other: Lifestyle interventionThe 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. |
| Interventional branch | – | –A lifestyle intervention following a holistic schedule was done in a subgroup of obese juveniles. |
Who may qualify
- Ages
- 3 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Probands are residents of Graz and from the federal state of styria.
Key inclusion criteria (1 listed)
- general healthy condition except overweightness/obesity, age below 55 years
Key exclusion criteria (1 listed)
- thyroid dysfunction, infections, chronic diseases (e.g. autoimmune, inflammatory), neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionAlso: lifestyle counselingRegular sports and dietary advices. Controlled by analysis of laboratory parameters, BMI change and performance diagnostics. No drugs included so far. | Other | Overweight/obese |
Primary outcome
Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention
Time frame: 12 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 16912132Pilz S, Mangge H, Wellnitz B, Seelhorst U, Winkelmann BR, Tiran B, Boehm BO, Marz W. Adiponectin and mortality in patients undergoing coronary angiography. J Clin Endocrinol Metab. 2006 Nov;91(11):4277-86. doi: 10.1210/jc.2006-0836. Epub 2006 Aug 15.
- Background: PubMed 18556000Murr C, Winklhofer-Roob BM, Schroecksnadel K, Maritschnegg M, Mangge H, Bohm BO, Winkelmann BR, Marz W, Fuchs D. Inverse association between serum concentrations of neopterin and antioxidants in patients with and without angiographic coronary artery disease. Atherosclerosis. 2009 Feb;202(2):543-9. doi: 10.1016/j.atherosclerosis.2008.04.047. Epub 2008 May 15.
- Background: PubMed 17578890Pachler C, Ikeoka D, Plank J, Weinhandl H, Suppan M, Mader JK, Bodenlenz M, Regittnig W, Mangge H, Pieber TR, Ellmerer M. Subcutaneous adipose tissue exerts proinflammatory cytokines after minimal trauma in humans. Am J Physiol Endocrinol Metab. 2007 Sep;293(3):E690-6. doi: 10.1152/ajpendo.00034.2007. Epub 2007 Jun 19.
- Background: PubMed 17392604Pilz S, Mangge H, Obermayer-Pietsch B, Marz W. Visfatin/pre-B-cell colony-enhancing factor: a protein with various suggested functions. J Endocrinol Invest. 2007 Feb;30(2):138-44. doi: 10.1007/BF03347412.
- Background: PubMed 21135756Arnold T, Brandlhofer S, Vrtikapa K, Stangl H, Hermann M, Zwiauer K, Mangge H, Karwautz A, Huemer J, Koller D, Schneider WJ, Strobl W. Effect of obesity on plasma clusterin, [corrected] a proposed modulator of leptin action. Pediatr Res. 2011 Mar;69(3):237-42. doi: 10.1203/PDR.0b013e31820930cb.
- Background: PubMed 21334626Fritsch P, Kleber M, Schlagenhauf A, Laschnik B, Fritsch M, Muntean W, Mangge H, Reinehr T. Normalization of haemostatic alterations in overweight children with weight loss due to lifestyle intervention. Atherosclerosis. 2011 May;216(1):170-3. doi: 10.1016/j.atherosclerosis.2011.01.042. Epub 2011 Feb 2.
- Background: PubMed 21647864Hasija R, Pistorio A, Ravelli A, Demirkaya E, Khubchandani R, Guseinova D, Malattia C, Canhao H, Harel L, Foell D, Wouters C, De Cunto C, Huemer C, Kimura Y, Mangge H, Minetti C, Nordal EB, Philippet P, Garozzo R, Martini A, Ruperto N; Pediatric Rheumatology International Trials Organization. Therapeutic approaches in the treatment of juvenile dermatomyositis in patients with recent-onset disease and in those experiencing disease flare: an international multicenter PRINTO study. Arthritis Rheum. 2011 Oct;63(10):3142-52. doi: 10.1002/art.30475.
- Background: PubMed 21753879Almer G, Wernig K, Saba-Lepek M, Haj-Yahya S, Rattenberger J, Wagner J, Gradauer K, Frascione D, Pabst G, Leitinger G, Mangge H, Zimmer A, Prassl R. Adiponectin-coated nanoparticles for enhanced imaging of atherosclerotic plaques. Int J Nanomedicine. 2011;6:1279-90. doi: 10.2147/IJN.S18739. Epub 2011 Jun 21.
- Background: PubMed 22022204Almer G, Saba-Lepek M, Haj-Yahya S, Rohde E, Strunk D, Frohlich E, Prassl R, Mangge H. Globular domain of adiponectin: promising target molecule for detection of atherosclerotic lesions. Biologics. 2011;5:95-105. doi: 10.2147/BTT.S22863. Epub 2011 Sep 7.
- Background: PubMed 24335156Landauer F, Huber G, Paulmichl K, O'Malley G, Mangge H, Weghuber D. Timely diagnosis of malalignment of the distal extremities is crucial in morbidly obese juveniles. Obes Facts. 2013;6(6):542-51. doi: 10.1159/000357280. Epub 2013 Dec 6.
- Background: PubMed 24330408Reininghaus EZ, McIntyre RS, Reininghaus B, Geisler S, Bengesser SA, Lackner N, Hecht K, Birner A, Kattnig F, Unterweger R, Kapfhammer HP, Zelzer S, Fuchs D, Mangge H. Tryptophan breakdown is increased in euthymic overweight individuals with bipolar disorder: a preliminary report. Bipolar Disord. 2014 Jun;16(4):432-40. doi: 10.1111/bdi.12166. Epub 2013 Dec 12.
- Background: PubMed 24140721Gradauer K, Barthelmes J, Vonach C, Almer G, Mangge H, Teubl B, Roblegg E, Dunnhaupt S, Frohlich E, Bernkop-Schnurch A, Prassl R. Liposomes coated with thiolated chitosan enhance oral peptide delivery to rats. J Control Release. 2013 Dec 28;172(3):872-8. doi: 10.1016/j.jconrel.2013.10.011. Epub 2013 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Mangge, Prof., MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Atherosclerosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harald Mangge, Prof., MD (+43 316 385 ext. 83340, harald.mangge@klinikum-graz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00482924, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.