Childhood ObesityNCT00823277
Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight
An observational study of Childhood Obesity and NAFLD (Non-alcoholic Fatty Liver Disease), run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
Definition: the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity. The specific aims are to; describe the degree of NAFLD among overweight and obese, Danish children. Read more about this study
- Who is it for?
- Ages 5 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, NAFLD (Non-alcoholic Fatty Liver Disease), Hypertension
- What is being tested?
- Chronic care multidisciplinary intervention of childhood obesity
- How many people
- 517 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Aug 2012
- 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 5 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark
Who may be able to join
- 5- 20 Years old.
- Adipose. BMI > 90 % percentile
- New patient in the Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
- Informed Consent
Who cannot join
- Drop-outs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen
Holbæk, 4300
About this study
Official title: Indicators for the Metabolic Syndrome as Well as the Influence of Different Gen-polymorphs on Weightloss and the Maintenance of Lower Weight Among Children in Treatment for Overweight
Definition:
the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity.
Read more
The specific aims are to;
- describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis; the degree for pediatric NAFLD among Danish Children was equal that found in other Caucasian paediatric study populations).
- investigate the effect of a multidisciplinary intervention treatment of 1 year on liver fat content. (hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat content in relation to changes in levels of fasting blood variables to see if any of them could be used as a clinical tool for monitoring hepatic steatosis in the clinic. (hypothesis; serum aminotransferases (separately and their ratio, respectively), serum insulin, and HOMA-IR could predict improvement in liver fat content
- Investigate the association between genetic variants and obesity.
- Conditions
- Childhood Obesity, NAFLD (Non-alcoholic Fatty Liver Disease), Hypertension, Hyperlipidemia, Insulin Sensitivity
- Being tested
- Chronic care multidisciplinary intervention of childhood obesity
- Medical subject headings
- Pediatric Obesity, Non-alcoholic Fatty Liver Disease, Hypertension, Hyperlipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic care multidisciplinary intervention of childhood obesityOther
Overweight and obese Children, 5-20 Years old, followed by Paediatricians and other Health Personals (multidisciplinary team). Included at their first visit in the clinic (baseline)and follow-up after ~ 1 Year.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Overweight and obese Children (BMI SDS > 90th percentile according to Danish BMI sheets) 5-20 Years of age. Recruited from the Paediatric department, University Hospital Holbaek, Region Zealand, Denmark, University of Copenhagen Receives: Other: Chronic care multidisciplinary intervention of childhood obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
weightloss
Measured: 1 Year
Secondary outcomes (1)
NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs
Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Hagedorn Research Institute, The Novo Nordisk Foundation Center for Basic Metabolic Research, Herlev Hospital
- Responsible party
- Principal investigator, Jens-Christian Holm, Zealand University Hospital
- Investigators
- Dorthe S. Bille, MD, Principal investigator, Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823277
- Sponsor's protocol ID
- 130109
- Other IDs
- SJ-98
- Status last verified
- Jul 2023
- First submitted
- 14 Jan 2009
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. MR spectroscopy of liver in overweight children and adolescents: investigation of (1)H T(2) relaxation times at 3T. Eur J Radiol. 2012 May;81(5):811-4. doi: 10.1016/j.ejrad.2011.02.017. Epub 2011 Mar 4.
PubMed 21377308Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. (1)H MRS assessment of hepatic steatosis in overweight children and adolescents: comparison between 3T and open 1T MR-systems. Abdom Imaging. 2013 Apr;38(2):315-9. doi: 10.1007/s00261-012-9930-2.
PubMed 22736224Bille DS, Chabanova E, Gamborg M, Fonvig CE, Nielsen TR, Thisted E, Thomsen HS, Holm JC. Liver fat content investigated by magnetic resonance spectroscopy in obese children and youths included in multidisciplinary treatment. Clin Obes. 2012 Feb;2(1-2):41-9. doi: 10.1111/j.1758-8111.2012.00038.x. Epub 2012 Apr 24.
PubMed 25586046
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicators for the Metabolic Syndrome as Well as the Influence of Different Gen-polymorphs on Weightloss and the Maintenance of Lower Weight Among Children in Treatment for Overweight
- ClinicalTrials.gov ID
- NCT00823277
- Acronym / sponsor ID
- 130109
- Conditions
- Childhood Obesity, NAFLD (Non-alcoholic Fatty Liver Disease), Hypertension, Hyperlipidemia, Insulin Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- University of Copenhagen, Hagedorn Research Institute, The Novo Nordisk Foundation Center for Basic Metabolic Research, Herlev Hospital
- Study start
- Jan 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Jan 2009 (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.
Definition:
the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity.
The specific aims are to;
- describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis; the degree for pediatric NAFLD among Danish Children was equal that found in other Caucasian paediatric study populations).
- investigate the effect of a multidisciplinary intervention treatment of 1 year on liver fat content. (hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat content in relation to changes in levels of fasting blood variables to see if any of them could be used as a clinical tool for monitoring hepatic steatosis in the clinic. (hypothesis; serum aminotransferases (separately and their ratio, respectively), serum insulin, and HOMA-IR could predict improvement in liver fat content
- Investigate the association between genetic variants and obesity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Chronic care multidisciplinary intervention of childhood obesityOverweight and obese Children (BMI SDS > 90th percentile according to Danish BMI sheets) 5-20 Years of age. Recruited from the Paediatric department, University Hospital Holbaek, Region Zealand, Denmark, University of Copenhagen |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark
Key inclusion criteria (4 listed)
- 5- 20 Years old.
- Adipose. BMI > 90 % percentile
- New patient in the Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
- Informed Consent
Key exclusion criteria (1 listed)
- Drop-outs
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 |
|---|---|---|
| Chronic care multidisciplinary intervention of childhood obesityOverweight and obese Children, 5-20 Years old, followed by Paediatricians and other Health Personals (multidisciplinary team). Included at their first visit in the clinic (baseline)and follow-up after ~ 1 Year. | Other | 1 |
Primary outcome
weightloss
Time frame: 1 Year
1 secondary outcome
NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs
Time frame: 1 Year
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 17 Jul 2023.
- Results publication: PubMed 21377308Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. MR spectroscopy of liver in overweight children and adolescents: investigation of (1)H T(2) relaxation times at 3T. Eur J Radiol. 2012 May;81(5):811-4. doi: 10.1016/j.ejrad.2011.02.017. Epub 2011 Mar 4.
- Results publication: PubMed 22736224Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. (1)H MRS assessment of hepatic steatosis in overweight children and adolescents: comparison between 3T and open 1T MR-systems. Abdom Imaging. 2013 Apr;38(2):315-9. doi: 10.1007/s00261-012-9930-2.
- Results publication: PubMed 25586046Bille DS, Chabanova E, Gamborg M, Fonvig CE, Nielsen TR, Thisted E, Thomsen HS, Holm JC. Liver fat content investigated by magnetic resonance spectroscopy in obese children and youths included in multidisciplinary treatment. Clin Obes. 2012 Feb;2(1-2):41-9. doi: 10.1111/j.1758-8111.2012.00038.x. Epub 2012 Apr 24.
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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.
Dorthe S. Bille, MD principal investigator
Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
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 NAFLD (Non-alcoholic Fatty Liver Disease), run by Holbaek Sygehus at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 17 Jul 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 Denmark. 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?
weightloss (time frame: 1 Year). 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 NCT00823277, which also lists 3 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 17 Jul 2023.