NCT02886013

Brief Summary

Background and Aims: The presence of the FTO rs9939609 and PPARy rs1801282 polymorphisms suggests changes in energy metabolism; this variation may be responsible for the development of various diseases including obesity. The aim of this study was to identify the presence of these polymorphisms in Mexican adolescents with overweight and obesity at high risk for developing diabetes. Methods and Results: This was a descriptive cross-sectional study, where 71 healthy adolescents (average age of 16) were included. Anthropometric measurements, Body mass index, as well as the determination of glucose, insulin and HOMA index were calculated from all the patients. The FTO rs9939609 and PPARy rs1801282 polymorphisms were determined by real-time PCR.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

August 21, 2016

Last Update Submit

August 28, 2016

Conditions

Keywords

prevalence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the FTO rs9939609 and PPARy rs1801282 polymorphisms.

    The aim of this study was to identify the presence of these polymorphisms in Mexican adolescents with overweight and obesity at high risk for developing diabetes.

    up to 24 months.

Study Arms (1)

Mexican adolescents

Students without known disease, between 14 and 18 years from the "Lic. Adolfo Lopez Mateos" Preparatory school of the Autonomous University of the State of Mexico (UAEMex).

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mexican adolescents with overweight and obesity at high risk for developing diabetes.

You may qualify if:

  • Students without known disease, between 14 and 18 years from the "Lic. Adolfo Lopez Mateos" Preparatory school of the Autonomous University of the State of Mexico (UAEMex).

You may not qualify if:

  • Those with a history of smoking, pregnancy or diagnosed with a chronic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

3 mL of venous blood (Vacutainer tubes) were taken in fasting. A sample remained frozen at -70°C (900 series Thermo Scientific) until DNA extraction. Genotyping DNA extraction was performed in the Magna Pure LC 2.0 Instrument (Roche, Germany) using the MagNA Pure LC DNA Isolation Kit 1 (Roche, Germany).

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • María del Socorro Camarillo Romero, PhD.

    Autonomous University of the State of Mexico

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 21, 2016

First Posted

September 1, 2016

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2015

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share