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Trial record 13 of 198 for:    Genetic AND exome sequencing

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
Sponsor:
Collaborators:
Health Promotion Board, Singapore
Genome Institute of Singapore A*Star, Singapore
Information provided by (Responsible Party):
Lee Yung Seng, National University, Singapore

Brief Summary:

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
Childhood Obesity

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Group/Cohort
Obese children

The obese subject must meet all of the following inclusion criteria to participate in this study:

  1. Ideal body weight for height (WFH) of at least 140% or BMI for age above 97th percentile
  2. Overweight before 10 years of age
  3. Informed consent from both obese children subject and legal representative e.g. parents
Family members of obese children

Family member must meet all of the following inclusion criteria to participate in this study:

  1. Must be parent or direct sibling of obese subject
  2. Informed consent from both subject and parent is subject is below 21 years of age



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. biomarkers, inflammatory markers and PBMC gene expressions between metabolically healthy obese and metabolically unhealthy obese [ Time Frame: 3 years ]
  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
As our study aims to identify susceptible genetic variants associated with early onset obesity, we will be recruiting 400 obese children to participate in this genetic study, in addition to the existing DNA samples we collected in a previous study. These 400 obese children will be recruited through NUH paediatric clinic and School Health Clinic at Health Promotion Board. We will also recruit family members of the obese children who are interested to join the research study. We will be using the DNA samples and information of 250 obese children previously recruited to the Obesity Genetic Study from January 2000 to December 2004 . We will also be performing WES on 500 lean adults (as controls) recruited for an ongoing study.
Criteria

Inclusion Criteria:

1.1. Inclusion Criteria

The obese subject must meet all of the following inclusion criteria to participate in this study:

  1. Ideal body weight for height (WFH) of at least 140% or BMI for age above 97th percentile
  2. Overweight before 10 years of age
  3. Informed consent from both obese children subject and legal representative e.g. parents

Family member must meet all of the following inclusion criteria to participate in this study:

  1. Must be parent or direct sibling of obese subject
  2. Informed consent from both subject and parent is subject is below 21 years of age

Exclusion Criteria:

All subjects meeting any of the exclusion criteria at baseline will be excluded from participation:

  1. Unfit for blood testing and OGTT testing
  2. No informed consent

Information from the National Library of Medicine

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


Locations
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Singapore
National University Hospital, Singapore
Singapore, Singapore, 119074
Health Promotion Board
Singapore, Singapore, 168937
Sponsors and Collaborators
National University, Singapore
Health Promotion Board, Singapore
Genome Institute of Singapore A*Star, Singapore
Investigators
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Principal Investigator: Yung Seng Lee, M.D, PhD National University Health System

Additional Information:

Publications:
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Responsible Party: Lee Yung Seng, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02418377     History of Changes
Other Study ID Numbers: NMRC/CIRG/1407/2014
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lee Yung Seng, National University, Singapore:
Obesity
Genetics
Whole exome sequencing
Children

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms