Genetic Determinants and Clinical Consequences of Early-onset Severe Obesity

NCT02645422 | Unknown

• 1 other identifier: HUCH43/2015
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. The investigators hypothesize that by exploring children with severe early-onset obesity they can find new obesity-related genetic defects and by exploring obesity-associated clinical manifestations the investigators can elucidate the outcomes of severe childhood obesity.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Number of patients with gene mutations or genetic variants in children with early-onset severe obesity

  Baseline, first day of enrollment

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study subjects include children and adolescent with severe, early-onset childhood obesity. Early-onset obesity is defined as height-adjusted weight \>60 % (corresponding to severe obesity) before the age of 7 years.

You may qualify if:

• children and adolescents age 10-18 years
• height-adjusted weight \>60 % before the age of 7 years.
• Finnish descent

You may not qualify if:

• patients with a known endocrine or genetic disorder underlying obesity (e.g. Prader-Willi syndrome, hypercortisolism, hypothyroidism)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Folkhälsan Researech Center: collaborator
• Karolinska Institutet: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Outi Mäkitie, Prof.

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: January 1, 2016
• Study Start: December 1, 2015
• Primary Completion: September 22, 2023
• Study Completion: December 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share