Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-07 @ 2:12 PM
Study NCT ID:
NCT03147261
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2017-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Comprehensive Intervention on the Cardiometabolic Risk in Children With Central Obesity (IGENOI)Obesity
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Organization:
Study Overview
Official Title:
Impacto de Una intervención Integral Sobre el Riesgo cardiometabólico en niños Con Obesidad Central: Estudio de Marcadores genéticos y epigenéticos
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IGENOI
Brief Summary:
Central obesity, present in the metabolic syndrome (MS), is associated with increased risk of insulin resistance (RI). The aim of the project is to evaluate the protective effect of comprehensive intervention (Mediterranean diet + physical activity) in the development of RI in children with central obesity based on genetic and epigenetic markers.
Detailed Description:
Objectives: 1) Apply a comprehensive therapeutic nutrition intervention program for monitoring the Mediterranean Diet (DM) slightly hypocaloric along with increased physical activity in children with central obesity 7-16 years). 2) Measure the effectiveness of this program by assessing changes in body composition, lifestyle and biological and molecular parameters (genetic and epigenetic).
Methodology: test randomized, longitudinal, controlled, two-year intervention field comparing a sample of 120 subjects from 7 to 16 years with central obesity, the effect of two interventions: a) intensive on lifestyle with a reduced calorie DM , physical activity and behavioral therapy, b) non-intensive with healthy diet recommendations following the usual pediatric advice. At 2, 6, 12 and 24 months after follow up changes will be assessed: a) the HOMA index, body fat, and the cardiovascular risk factors, b) diet, sleep patterns, physical exercise using questionnaires and accelerometers (intervention group), and c) the quality of life. genetic and epigenetic markers will be evaluated by genotyping SNPs genes related to RI; and the analysis of: a) DNA methylation in genes related to insulin resistance, b) expression of microRNAs and target genes related to insulin resistance and c) measure the length of telomeres. The therapeutic program will consist of individual sessions and group workshops for the patient and the family.
Methodology: test randomized, longitudinal, controlled, two-year intervention field comparing a sample of 120 subjects from 7 to 16 years with central obesity, the effect of two interventions: a) intensive on lifestyle with a reduced calorie DM , physical activity and behavioral therapy, b) non-intensive with healthy diet recommendations following the usual pediatric advice. At 2, 6, 12 and 24 months after follow up changes will be assessed: a) the HOMA index, body fat, and the cardiovascular risk factors, b) diet, sleep patterns, physical exercise using questionnaires and accelerometers (intervention group), and c) the quality of life. genetic and epigenetic markers will be evaluated by genotyping SNPs genes related to RI; and the analysis of: a) DNA methylation in genes related to insulin resistance, b) expression of microRNAs and target genes related to insulin resistance and c) measure the length of telomeres. The therapeutic program will consist of individual sessions and group workshops for the patient and the family.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: