An observational study in Childhood Obesity, NAFLD (Non-alcoholic Fatty Liver Disease) and Hypertension, sponsored by Holbaek Sygehus. Completed at 1 site in Denmark. Open to participants aged 5 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Holbaek Sygehus · Observational
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;
(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
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 517 is above the median of 180 across 235 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Chronic care multidisciplinary intervention of childhood obesity
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.
weightloss
Time frame: 1 Year
NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs
Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R
Time frame: 1 Year
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Holbaek Sygehus