ObesityNCT01605123
Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
An observational study of Obesity, run by University of Leipzig at 2 sites in Germany.
Trial summary
The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age. To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of… Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2007to Dec 2017
- 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 6 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Obese children from our out-patient department in Leipzig, Germany Lean children community-based from Leipzig
Who may be able to join
- height -2 to +2 SDS
- pubertal stage adequate for age
- no medications
- written consent of guardians and children≥12y
- weight ≥ -2 SDS
Who cannot join
- secondary/syndromal obesity
- known existing hypertension
- chronic disease (eg. errors of metabolism)
- acute illness (eg. respiratory tract infection)
- previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig
Leipzig, Saxony, 04103
University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research
Leipzig, Saxony, 04103
About this study
Official title: Leipzig Artherobesity Childhood Cohort
The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age.
To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years.
In addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.
- Conditions
- Obesity
- Keywords
- endothelial function, children, obesity, cardiovascular dysfunction, carotid intima media thickness, blood pressure, oral glucose tolerance test
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean children | n=100 (anticipated), n=70 currently Age: 6-25 years BMI-SDS: -1.88 to +1.23 , currently -0.25±0.77; Height-SDS: > - 2 SDS, currently 0.03±1.07; | |
| Obese children | n=106 Age: 6-25 years BMI-SDS: >1.23 , currently 2.41±0.52; Height-SDS: > - 2 SDS, currently 0.80±1.18; | |
| Obese Exercise Group | Obese children will engage in increased physical activity (one to two lessons per week) at 40-60 and 60-80% of maximal exercise capacity (n=50 each anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes. | |
| Classical Lifestyle Intervention | Obese children will receive a classical lifestyle intervention, including dietary, activity and psychosocial counselling (n=50 anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular dysfunction
Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startApr 2007
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Antje Koerner, Prof. Dr. med., University of Leipzig
- Investigators
- Antje Körner, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605123
- Sponsor's protocol ID
- KFO152/SFB1052-C5
- Status last verified
- Nov 2023
- First submitted
- 22 May 2012
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Korner A, Kratzsch J, Gausche R, Schaab M, Erbs S, Kiess W. New predictors of the metabolic syndrome in children--role of adipocytokines. Pediatr Res. 2007 Jun;61(6):640-5. doi: 10.1203/01.pdr.0000262638.48304.ef.
PubMed 17426657Landgraf K, Friebe D, Ullrich T, Kratzsch J, Dittrich K, Herberth G, Adams V, Kiess W, Erbs S, Korner A. Chemerin as a mediator between obesity and vascular inflammation in children. J Clin Endocrinol Metab. 2012 Apr;97(4):E556-64. doi: 10.1210/jc.2011-2937. Epub 2012 Mar 21.
PubMed 22438234Raschpichler MC, Sorge I, Hirsch W, Mende M, Sergeyev E, Kruber D, Koerner A, Schick F. Evaluating childhood obesity: magnetic resonance-based quantification of abdominal adipose tissue and liver fat in children. Rofo. 2012 Apr;184(4):324-32. doi: 10.1055/s-0031-1299094. Epub 2012 Feb 9.
PubMed 22322443Friebe D, Neef M, Kratzsch J, Erbs S, Dittrich K, Garten A, Petzold-Quinque S, Bluher S, Reinehr T, Stumvoll M, Bluher M, Kiess W, Korner A. Leucocytes are a major source of circulating nicotinamide phosphoribosyltransferase (NAMPT)/pre-B cell colony (PBEF)/visfatin linking obesity and inflammation in humans. Diabetologia. 2011 May;54(5):1200-11. doi: 10.1007/s00125-010-2042-z. Epub 2011 Feb 6.
PubMed 21298414Friebe D, Neef M, Erbs S, Dittrich K, Kratzsch J, Kovacs P, Bluher M, Kiess W, Korner A. Retinol binding protein 4 (RBP4) is primarily associated with adipose tissue mass in children. Int J Pediatr Obes. 2011 Jun;6(2-2):e345-52. doi: 10.3109/17477166.2010.491228. Epub 2010 Oct 15.
PubMed 20950077Korner A, Neef M, Friebe D, Erbs S, Kratzsch J, Dittrich K, Bluher S, Kapellen TM, Kovacs P, Stumvoll M, Bluher M, Kiess W. Vaspin is related to gender, puberty and deteriorating insulin sensitivity in children. Int J Obes (Lond). 2011 Apr;35(4):578-86. doi: 10.1038/ijo.2010.196. Epub 2010 Sep 21.
PubMed 20856257Ehehalt S, Wiegand S, Korner A, Schweizer R, Liesenkotter KP, Partsch CJ, Blumenstock G, Spielau U, Denzer C, Ranke MB, Neu A, Binder G, Wabitsch M, Kiess W, Reinehr T. Diabetes screening in overweight and obese children and adolescents: choosing the right test. Eur J Pediatr. 2017 Jan;176(1):89-97. doi: 10.1007/s00431-016-2807-6. Epub 2016 Nov 25.
PubMed 27888412Ehehalt S, Wiegand S, Korner A, Schweizer R, Liesenkotter KP, Partsch CJ, Blumenstock G, Spielau U, Denzer C, Ranke MB, Neu A, Binder G, Wabitsch M, Kiess W, Reinehr T. Low association between fasting and OGTT stimulated glucose levels with HbA1c in overweight children and adolescents. Pediatr Diabetes. 2017 Dec;18(8):734-741. doi: 10.1111/pedi.12461. Epub 2016 Nov 22.
PubMed 27873429Schreier M, Schwartze JT, Landgraf K, Scheuermann K, Erbs S, Herberth G, Pospisilik JA, Kratzsch J, Kiess W, Korner A. Osteopontin is BMI-independently Related to Early Endothelial Dysfunction in Children. J Clin Endocrinol Metab. 2016 Nov;101(11):4161-4169. doi: 10.1210/jc.2016-2238. Epub 2016 Aug 29.
PubMed 27571184Felix JF, Bradfield JP, Monnereau C, van der Valk RJ, Stergiakouli E, Chesi A, Gaillard R, Feenstra B, Thiering E, Kreiner-Moller E, Mahajan A, Pitkanen N, Joro R, Cavadino A, Huikari V, Franks S, Groen-Blokhuis MM, Cousminer DL, Marsh JA, Lehtimaki T, Curtin JA, Vioque J, Ahluwalia TS, Myhre R, Price TS, Vilor-Tejedor N, Yengo L, Grarup N, Ntalla I, Ang W, Atalay M, Bisgaard H, Blakemore AI, Bonnefond A, Carstensen L; Bone Mineral Density in Childhood Study (BMDCS); Early Genetics and Lifecourse Epidemiology (EAGLE) consortium; Eriksson J, Flexeder C, Franke L, Geller F, Geserick M, Hartikainen AL, Haworth CM, Hirschhorn JN, Hofman A, Holm JC, Horikoshi M, Hottenga JJ, Huang J, Kadarmideen HN, Kahonen M, Kiess W, Lakka HM, Lakka TA, Lewin AM, Liang L, Lyytikainen LP, Ma B, Magnus P, McCormack SE, McMahon G, Mentch FD, Middeldorp CM, Murray CS, Pahkala K, Pers TH, Pfaffle R, Postma DS, Power C, Simpson A, Sengpiel V, Tiesler CM, Torrent M, Uitterlinden AG, van Meurs JB, Vinding R, Waage J, Wardle J, Zeggini E, Zemel BS, Dedoussis GV, Pedersen O, Froguel P, Sunyer J, Plomin R, Jacobsson B, Hansen T, Gonzalez JR, Custovic A, Raitakari OT, Pennell CE, Widen E, Boomsma DI, Koppelman GH, Sebert S, Jarvelin MR, Hypponen E, McCarthy MI, Lindi V, Harri N, Korner A, Bonnelykke K, Heinrich J, Melbye M, Rivadeneira F, Hakonarson H, Ring SM, Smith GD, Sorensen TI, Timpson NJ, Grant SF, Jaddoe VW; Early Growth Genetics (EGG) Consortium; Bone Mineral Density in Childhood Study BMDCS. Genome-wide association analysis identifies three new susceptibility loci for childhood body mass index. Hum Mol Genet. 2016 Jan 15;25(2):389-403. doi: 10.1093/hmg/ddv472. Epub 2015 Nov 24.
PubMed 26604143Breitling C, Gross A, Buttner P, Weise S, Schleinitz D, Kiess W, Scholz M, Kovacs P, Korner A. Genetic Contribution of Variants near SORT1 and APOE on LDL Cholesterol Independent of Obesity in Children. PLoS One. 2015 Sep 16;10(9):e0138064. doi: 10.1371/journal.pone.0138064. eCollection 2015.
PubMed 26375028Qi Q, Downer MK, Kilpelainen TO, Taal HR, Barton SJ, Ntalla I, Standl M, Boraska V, Huikari V, Kiefte-de Jong JC, Korner A, Lakka TA, Liu G, Magnusson J, Okuda M, Raitakari O, Richmond R, Scott RA, Bailey ME, Scheuermann K, Holloway JW, Inskip H, Isasi CR, Mossavar-Rahmani Y, Jaddoe VW, Laitinen J, Lindi V, Melen E, Pitsiladis Y, Pitkanen N, Snieder H, Heinrich J, Timpson NJ, Wang T, Yuji H, Zeggini E, Dedoussis GV, Kaplan RC, Wylie-Rosett J, Loos RJ, Hu FB, Qi L. Dietary Intake, FTO Genetic Variants, and Adiposity: A Combined Analysis of Over 16,000 Children and Adolescents. Diabetes. 2015 Jul;64(7):2467-76. doi: 10.2337/db14-1629. Epub 2015 Feb 26.
PubMed 25720386Loffler D, Muller U, Scheuermann K, Friebe D, Gesing J, Bielitz J, Erbs S, Landgraf K, Wagner IV, Kiess W, Korner A. Serum irisin levels are regulated by acute strenuous exercise. J Clin Endocrinol Metab. 2015 Apr;100(4):1289-99. doi: 10.1210/jc.2014-2932. Epub 2015 Jan 27.
PubMed 25625801Mangner N, Scheuermann K, Winzer E, Wagner I, Hoellriegel R, Sandri M, Zimmer M, Mende M, Linke A, Kiess W, Schuler G, Korner A, Erbs S. Childhood obesity: impact on cardiac geometry and function. JACC Cardiovasc Imaging. 2014 Dec;7(12):1198-205. doi: 10.1016/j.jcmg.2014.08.006. Epub 2014 Oct 8.
PubMed 25306542Korner A, Wiegand S, Hungele A, Tuschy S, Otto KP, l'Allemand-Jander D, Widhalm K, Kiess W, Holl RW; APV initiative; German Competence Net Obesity. Longitudinal multicenter analysis on the course of glucose metabolism in obese children. Int J Obes (Lond). 2013 Jul;37(7):931-6. doi: 10.1038/ijo.2012.163. Epub 2012 Oct 2.
PubMed 23032406
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leipzig Artherobesity Childhood Cohort
- ClinicalTrials.gov ID
- NCT01605123
- Acronym / sponsor ID
- KFO152/SFB1052-C5
- Conditions
- Obesity
- Keywords
- endothelial function, children, obesity, cardiovascular dysfunction, carotid intima media thickness, blood pressure, oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Apr 2007 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 May 2012 (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.
The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age.
To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years.
In addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lean children | – | –n=100 (anticipated), n=70 currently Age: 6-25 years BMI-SDS: -1.88 to +1.23 , currently -0.25±0.77; Height-SDS: > - 2 SDS, currently 0.03±1.07; |
| Obese children | – | –n=106 Age: 6-25 years BMI-SDS: >1.23 , currently 2.41±0.52; Height-SDS: > - 2 SDS, currently 0.80±1.18; |
| Obese Exercise Group | – | –Obese children will engage in increased physical activity (one to two lessons per week) at 40-60 and 60-80% of maximal exercise capacity (n=50 each anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes. |
| Classical Lifestyle Intervention | – | –Obese children will receive a classical lifestyle intervention, including dietary, activity and psychosocial counselling (n=50 anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Obese children from our out-patient department in Leipzig, Germany Lean children community-based from Leipzig
Key inclusion criteria (5 listed)
- height -2 to +2 SDS
- pubertal stage adequate for age
- no medications
- written consent of guardians and children≥12y
- weight ≥ -2 SDS
Key exclusion criteria (5 listed)
- secondary/syndromal obesity
- known existing hypertension
- chronic disease (eg. errors of metabolism)
- acute illness (eg. respiratory tract infection)
- previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiovascular dysfunction
Time frame: 7 years
Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 17426657Korner A, Kratzsch J, Gausche R, Schaab M, Erbs S, Kiess W. New predictors of the metabolic syndrome in children--role of adipocytokines. Pediatr Res. 2007 Jun;61(6):640-5. doi: 10.1203/01.pdr.0000262638.48304.ef.
- Results publication: PubMed 22438234Landgraf K, Friebe D, Ullrich T, Kratzsch J, Dittrich K, Herberth G, Adams V, Kiess W, Erbs S, Korner A. Chemerin as a mediator between obesity and vascular inflammation in children. J Clin Endocrinol Metab. 2012 Apr;97(4):E556-64. doi: 10.1210/jc.2011-2937. Epub 2012 Mar 21.
- Results publication: PubMed 22322443Raschpichler MC, Sorge I, Hirsch W, Mende M, Sergeyev E, Kruber D, Koerner A, Schick F. Evaluating childhood obesity: magnetic resonance-based quantification of abdominal adipose tissue and liver fat in children. Rofo. 2012 Apr;184(4):324-32. doi: 10.1055/s-0031-1299094. Epub 2012 Feb 9.
- Results publication: PubMed 21298414Friebe D, Neef M, Kratzsch J, Erbs S, Dittrich K, Garten A, Petzold-Quinque S, Bluher S, Reinehr T, Stumvoll M, Bluher M, Kiess W, Korner A. Leucocytes are a major source of circulating nicotinamide phosphoribosyltransferase (NAMPT)/pre-B cell colony (PBEF)/visfatin linking obesity and inflammation in humans. Diabetologia. 2011 May;54(5):1200-11. doi: 10.1007/s00125-010-2042-z. Epub 2011 Feb 6.
- Results publication: PubMed 20950077Friebe D, Neef M, Erbs S, Dittrich K, Kratzsch J, Kovacs P, Bluher M, Kiess W, Korner A. Retinol binding protein 4 (RBP4) is primarily associated with adipose tissue mass in children. Int J Pediatr Obes. 2011 Jun;6(2-2):e345-52. doi: 10.3109/17477166.2010.491228. Epub 2010 Oct 15.
- Results publication: PubMed 20856257Korner A, Neef M, Friebe D, Erbs S, Kratzsch J, Dittrich K, Bluher S, Kapellen TM, Kovacs P, Stumvoll M, Bluher M, Kiess W. Vaspin is related to gender, puberty and deteriorating insulin sensitivity in children. Int J Obes (Lond). 2011 Apr;35(4):578-86. doi: 10.1038/ijo.2010.196. Epub 2010 Sep 21.
- Results publication: PubMed 27888412Ehehalt S, Wiegand S, Korner A, Schweizer R, Liesenkotter KP, Partsch CJ, Blumenstock G, Spielau U, Denzer C, Ranke MB, Neu A, Binder G, Wabitsch M, Kiess W, Reinehr T. Diabetes screening in overweight and obese children and adolescents: choosing the right test. Eur J Pediatr. 2017 Jan;176(1):89-97. doi: 10.1007/s00431-016-2807-6. Epub 2016 Nov 25.
- Results publication: PubMed 27873429Ehehalt S, Wiegand S, Korner A, Schweizer R, Liesenkotter KP, Partsch CJ, Blumenstock G, Spielau U, Denzer C, Ranke MB, Neu A, Binder G, Wabitsch M, Kiess W, Reinehr T. Low association between fasting and OGTT stimulated glucose levels with HbA1c in overweight children and adolescents. Pediatr Diabetes. 2017 Dec;18(8):734-741. doi: 10.1111/pedi.12461. Epub 2016 Nov 22.
- Results publication: PubMed 27571184Schreier M, Schwartze JT, Landgraf K, Scheuermann K, Erbs S, Herberth G, Pospisilik JA, Kratzsch J, Kiess W, Korner A. Osteopontin is BMI-independently Related to Early Endothelial Dysfunction in Children. J Clin Endocrinol Metab. 2016 Nov;101(11):4161-4169. doi: 10.1210/jc.2016-2238. Epub 2016 Aug 29.
- Results publication: PubMed 26604143Felix JF, Bradfield JP, Monnereau C, van der Valk RJ, Stergiakouli E, Chesi A, Gaillard R, Feenstra B, Thiering E, Kreiner-Moller E, Mahajan A, Pitkanen N, Joro R, Cavadino A, Huikari V, Franks S, Groen-Blokhuis MM, Cousminer DL, Marsh JA, Lehtimaki T, Curtin JA, Vioque J, Ahluwalia TS, Myhre R, Price TS, Vilor-Tejedor N, Yengo L, Grarup N, Ntalla I, Ang W, Atalay M, Bisgaard H, Blakemore AI, Bonnefond A, Carstensen L; Bone Mineral Density in Childhood Study (BMDCS); Early Genetics and Lifecourse Epidemiology (EAGLE) consortium; Eriksson J, Flexeder C, Franke L, Geller F, Geserick M, Hartikainen AL, Haworth CM, Hirschhorn JN, Hofman A, Holm JC, Horikoshi M, Hottenga JJ, Huang J, Kadarmideen HN, Kahonen M, Kiess W, Lakka HM, Lakka TA, Lewin AM, Liang L, Lyytikainen LP, Ma B, Magnus P, McCormack SE, McMahon G, Mentch FD, Middeldorp CM, Murray CS, Pahkala K, Pers TH, Pfaffle R, Postma DS, Power C, Simpson A, Sengpiel V, Tiesler CM, Torrent M, Uitterlinden AG, van Meurs JB, Vinding R, Waage J, Wardle J, Zeggini E, Zemel BS, Dedoussis GV, Pedersen O, Froguel P, Sunyer J, Plomin R, Jacobsson B, Hansen T, Gonzalez JR, Custovic A, Raitakari OT, Pennell CE, Widen E, Boomsma DI, Koppelman GH, Sebert S, Jarvelin MR, Hypponen E, McCarthy MI, Lindi V, Harri N, Korner A, Bonnelykke K, Heinrich J, Melbye M, Rivadeneira F, Hakonarson H, Ring SM, Smith GD, Sorensen TI, Timpson NJ, Grant SF, Jaddoe VW; Early Growth Genetics (EGG) Consortium; Bone Mineral Density in Childhood Study BMDCS. Genome-wide association analysis identifies three new susceptibility loci for childhood body mass index. Hum Mol Genet. 2016 Jan 15;25(2):389-403. doi: 10.1093/hmg/ddv472. Epub 2015 Nov 24.
- Results publication: PubMed 26375028Breitling C, Gross A, Buttner P, Weise S, Schleinitz D, Kiess W, Scholz M, Kovacs P, Korner A. Genetic Contribution of Variants near SORT1 and APOE on LDL Cholesterol Independent of Obesity in Children. PLoS One. 2015 Sep 16;10(9):e0138064. doi: 10.1371/journal.pone.0138064. eCollection 2015.
- Results publication: PubMed 25720386Qi Q, Downer MK, Kilpelainen TO, Taal HR, Barton SJ, Ntalla I, Standl M, Boraska V, Huikari V, Kiefte-de Jong JC, Korner A, Lakka TA, Liu G, Magnusson J, Okuda M, Raitakari O, Richmond R, Scott RA, Bailey ME, Scheuermann K, Holloway JW, Inskip H, Isasi CR, Mossavar-Rahmani Y, Jaddoe VW, Laitinen J, Lindi V, Melen E, Pitsiladis Y, Pitkanen N, Snieder H, Heinrich J, Timpson NJ, Wang T, Yuji H, Zeggini E, Dedoussis GV, Kaplan RC, Wylie-Rosett J, Loos RJ, Hu FB, Qi L. Dietary Intake, FTO Genetic Variants, and Adiposity: A Combined Analysis of Over 16,000 Children and Adolescents. Diabetes. 2015 Jul;64(7):2467-76. doi: 10.2337/db14-1629. Epub 2015 Feb 26.
- Link to Prof. Dr. med. Antje Körner's research group: "Childhood obesity"Link provided by the sponsor.
- University Children's Hospital Leipzig (Germany)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Antje Körner, MD principal investigator
University of Leipzig
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Leipzig at 2 sites in Germany.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular dysfunction (time frame: 7 years). 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 NCT01605123, which also lists 17 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 7 Nov 2023.