Childhood ObesityNCT02208141
Leipzig Adipose Tissue Childhood Cohort
An observational study of Childhood Obesity and Insulin Resistance, run by University of Leipzig at 1 site in Germany.
Trial summary
In this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Insulin Resistance
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: children and adolescents undergoing surgery at the University Hospital Leipzig
Who may be able to join
- body weight: 3000 g - 180 kg
- suitable surgical procedure
- signed informed consent by the guardians and the study participant, if older 12 years
Who cannot join
- severe chronic and inflammatory diseases
- acute or chronic infections
- oncological diseases
- clotting disorders
- complications during surgical procedure
- drug treatment
- nil by mouth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Center for Pediatric Research Leipzig (CPL)
Leipzig, Saxony, 04103
Antje Körner, Prof. Dr., 0049/(0)341-9726854, Antje.Koerner@medizin.uni-leipzig.de
About this study
Official title: Determinants of Adipose Tissue Development and Obesity in Children and Adolescents
In this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. The investigators aim to identify and characterize mechanisms and molecular targets that affect the development of adipose tissue and ensuing obesity in childhood and adolescence.
Read the detailed description
The investigators aim to identify how adipose tissue dysfunction in childhood contributes to the development of obesity and related comorbidities and to characterize factors that play a role in the development of adipose dysfunction in children. The investigators will employ a translational approach which is based on the characterization of adipose tissue biology in samples of children to determine alterations leading to adipose tissue dysfunction. These include assessment of the composition (including BAT), remodeling, function, metabolism and inflammation of adipose tissue as well as the adipokine profile. For the assessment of clinical relevance, these experimental data will then be correlated with the clinical phenotype. Finally, we aim to identify factors responsible for early adipose tissue dysfunction and characterize them for their clinical and functional relevance.
- Conditions
- Childhood Obesity, Insulin Resistance
- Keywords
- children, obesity, adipose tissue dysfunction, inflammation, macrophage infiltration, insulin resistance, dyslipidemia
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Obesity, Inflammation, Dyslipidemias
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 and obese children and adolescents | study cohort may be stratified for lean (definded as BMI <1.28 SDS) and overweight/obese (definded as BMI>= 1.28 SDS) children for posthoc analyses no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue dysfunction
Adipose tissue dysfunction is assessed by evaluation of adipocyte size and number (hypertrophy vs. hyperplasia), adipocyte proliferation and differentiation, (lipid) cellular metabolism, inflammation, gene expression, fibrosis, and others; the association of AT dysfunction with clincial phenotype will be assessed
Measured: 10 years
Secondary outcomes (2)
Presence of brown adipose tissue (BAT)
Adipose tissue samples will be evaluated for the presence of BAT on histological and molecular level and association with clinical phenotype will be investigated
Measured: 10 years
Inflammation of adipose tissue
Inflammation will be assessed by evaluating macrophage infiltration on histological and molecular expression level. Also, association with clinical phenotype will be assessed.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startOct 2010
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antje Koerner, Prof. Dr. med., University of Leipzig
- Investigators
- Antje Körner, Prof. Dr., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208141
- Sponsor's protocol ID
- IFB ADI K7-10
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2014
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kempf E, Landgraf K, Vogel T, Spielau U, Stein R, Raschpichler M, Kratzsch J, Kiess W, Stanik J, Korner A. Associations of GHR, IGF-1 and IGFBP-3 expression in adipose tissue cells with obesity-related alterations in corresponding circulating levels and adipose tissue function in children. Adipocyte. 2022 Dec;11(1):630-642. doi: 10.1080/21623945.2022.2148886.
PubMed 36384443Loffler D, Landgraf K, Rockstroh D, Schwartze JT, Dunzendorfer H, Kiess W, Korner A. METRNL decreases during adipogenesis and inhibits adipocyte differentiation leading to adipocyte hypertrophy in humans. Int J Obes (Lond). 2017 Jan;41(1):112-119. doi: 10.1038/ijo.2016.180. Epub 2016 Oct 17.
PubMed 27748745
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
- Determinants of Adipose Tissue Development and Obesity in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02208141
- Acronym / sponsor ID
- IFB ADI K7-10
- Conditions
- Childhood Obesity, Insulin Resistance
- Keywords
- children, obesity, adipose tissue dysfunction, inflammation, macrophage infiltration, insulin resistance, dyslipidemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Aug 2014 (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.
In this study the investigators hypothesize that pathological alterations in adipose tissue biology already occur during the development and progression of obesity in children and adolescents. The investigators aim to identify and characterize mechanisms and molecular targets that affect the development of adipose tissue and ensuing obesity in childhood and adolescence.
Detailed description
The investigators aim to identify how adipose tissue dysfunction in childhood contributes to the development of obesity and related comorbidities and to characterize factors that play a role in the development of adipose dysfunction in children. The investigators will employ a translational approach which is based on the characterization of adipose tissue biology in samples of children to determine alterations leading to adipose tissue dysfunction. These include assessment of the composition (including BAT), remodeling, function, metabolism and inflammation of adipose tissue as well as the adipokine profile. For the assessment of clinical relevance, these experimental data will then be correlated with the clinical phenotype. Finally, we aim to identify factors responsible for early adipose tissue dysfunction and characterize them for their clinical and functional relevance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lean and obese children and adolescents | – | –study cohort may be stratified for lean (definded as BMI <1.28 SDS) and overweight/obese (definded as BMI>= 1.28 SDS) children for posthoc analyses no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children and adolescents undergoing surgery at the University Hospital Leipzig
Key inclusion criteria (3 listed)
- body weight: 3000 g - 180 kg
- suitable surgical procedure
- signed informed consent by the guardians and the study participant, if older 12 years
Key exclusion criteria (7 listed)
- severe chronic and inflammatory diseases
- acute or chronic infections
- oncological diseases
- clotting disorders
- complications during surgical procedure
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
Adipose tissue dysfunction
Time frame: 10 years
Adipose tissue dysfunction is assessed by evaluation of adipocyte size and number (hypertrophy vs. hyperplasia), adipocyte proliferation and differentiation, (lipid) cellular metabolism, inflammation, gene expression, fibrosis, and others; the association of AT dysfunction with clincial phenotype will be assessed
2 secondary outcomes
Presence of brown adipose tissue (BAT)
Time frame: 10 years
Inflammation of adipose tissue
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 36384443Kempf E, Landgraf K, Vogel T, Spielau U, Stein R, Raschpichler M, Kratzsch J, Kiess W, Stanik J, Korner A. Associations of GHR, IGF-1 and IGFBP-3 expression in adipose tissue cells with obesity-related alterations in corresponding circulating levels and adipose tissue function in children. Adipocyte. 2022 Dec;11(1):630-642. doi: 10.1080/21623945.2022.2148886.
- Derived from this study: PubMed 27748745Loffler D, Landgraf K, Rockstroh D, Schwartze JT, Dunzendorfer H, Kiess W, Korner A. METRNL decreases during adipogenesis and inhibits adipocyte differentiation leading to adipocyte hypertrophy in humans. Int J Obes (Lond). 2017 Jan;41(1):112-119. doi: 10.1038/ijo.2016.180. Epub 2016 Oct 17.
- Link to Prof. Dr. med. Antje Körner's research group: "childhood obesity"Link provided by the sponsor.
- Link to University Children's Hospital LeipzigLink provided by the sponsor.
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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.
Antje Körner, Prof. Dr. principal investigator
University of Leipzig
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 Childhood Obesity and Insulin Resistance, run by University of Leipzig at 1 site 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 3 inclusion and 7 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: looking for participants now, 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antje Körner, Prof. Dr. (0049/(0)341-9726854, Antje.Koerner@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose tissue dysfunction (time frame: 10 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 NCT02208141, which also lists 2 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.