Whole-exome Sequencing in Childhood Obesity
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|ClinicalTrials.gov Identifier: NCT02418377|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2015
Last Update Posted : March 13, 2019
Obesity is a complex multifactorial disease where genetics play an important role in predisposing children to early onset obesity. Though many obesity susceptible genes and variants have been identified with obesity, the most common obesity gene, MC4R only accounts for 5% of all early onset obesity cases. This implies that there may be more obesity related genes and variants that need to be unravelled to further delineate the relationship between obesity and genetics. The investigators propose in screening the exonic regions of all the genes in obese subjects using whole-exome sequencing (WES) to discover novel obesity related variants and genes.
Primary hypothesis The investigators hypothesized that our paediatric subjects with early-onset severe obesity will have strong genetic predisposition and therefore the cohort would be enriched with obesity susceptibility genetic variants.
Secondary hypothesis The investigators hypothesized that there is increasing prevalence of, and possibly worsening, obesity-related complications (namely glucose intolerance, hypertension, metabolic syndrome, non-alcoholic fatty liver disease) in our severely obese children, as compared to 15 years ago, due to an increasingly obesogenic environment promoting unhealthy lifestyle and eating habits.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||800 participants|
|Target Follow-Up Duration:||3 Weeks|
|Official Title:||Whole-exome Sequencing to Identify Genetic Variants Associated With Severe Childhood Obesity, and Tracking the Changing Prevalence of Obesity Related Complications|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2020|
The obese subject must meet all of the following inclusion criteria to participate in this study:
Family members of obese children
Family member must meet all of the following inclusion criteria to participate in this study:
- Identify novel obesity genes and variants using whole-exome sequencing (WES) in our local Singaporean obese children. [ Time Frame: 3 years ]whole exom sequencing data
- Assess and compare the metabolic phenotype of the current severely obese children and severely obese children recruited in a similar fashion 15 years ago by the obesity gene study (OGS) group. [ Time Frame: 3 years ]metabolic measures
- biomarkers, inflammatory markers and PBMC gene expressions between metabolically healthy obese and metabolically unhealthy obese [ Time Frame: 3 years ]
- Stool microbiota/metagenomics in obese children, and metabolic health [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
15-19mls of blood will be extracted from each subject. Blood will be processed to obtain plasma/serum and DNA will be extracted from blood cells.
Plasma/serum and DNA samples will be stored at -80degree Celsius.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418377
|National University Hospital, Singapore|
|Singapore, Singapore, 119074|
|Health Promotion Board|
|Singapore, Singapore, 168937|
|Principal Investigator:||Yung Seng Lee, M.D, PhD||National University Health System|