Metabolic SyndromeNCT02886013
FTO rs9939609 and PPARy rs1801282 Polymorphisms in Mexican Adolescents
An observational study of Metabolic Syndrome and Insulin Resistance, run by Asociación Científica Latina A.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Mexican adolescents with overweight and obesity at high risk for developing diabetes.
Who may be able to join
- 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).
Who cannot join
- Those with a history of smoking, pregnancy or diagnosed with a chronic diseases.
About this study
Official title: FTO rs9939609 and PPARy rs1801282 Polymorphisms in Mexican Adolescents With Overweight and Obesity at High Risk for Developing Diabetes
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.
Read the detailed description
Study Population 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), were invited to participate.
Anthropometry The body mass index (BMI) was calculated as weight (kg) divided by height (m) squared with conventional stadiometer; dividing the results in normal, overweight and obesity according to the classification of the World Health Organization (WHO), specifically for adolescents by gender and age.
Laboratory 3 mL of venous blood (Vacutainer tubes) were taken in fasting. The concentration of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides were determined by enzymatic methods (Randox Laboratories Ltd, County Antrim, UK); whereas leptin and adiponectin concentrations were determined by the immunosorbent assay (ELISA) (Invitrogen MR Frederyck MD USA). 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). After extraction, the DNA was quantified using a NanoPhotometer (Implen GmbH, Germany), reporting concentration (μg/ml) and purity (260/280 absorbance). Genotyping was performed by polymerase chain reaction (PCR) Life express thermal cycler (Bioer, China). The primers and conditions for each polymorphism are listed in Table 1.
The oligonucleotides were designed using the Primer Quest web tool (Integrated DNA Technologies, Inc., CA, USA) and synthesized at the Synthesis and DNA Sequencing Unit of the National Autonomous University of Mexico (UNAM) Institute of Biotechnology (Cuernavaca, Morelos, Mexico). A search was performed in BLAST to verify the correct hybridization. The final products were visualized in 2% agarose gels, stained with ethidium bromide, and visualized under an UV transilluminator (Gel Logic 212 Pro, Carestream, USA). To confirm the detection of polymorphisms sequencing was performed at the National Institute of Genomic Medicine (INMEGEN), Mexico City.
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Keywords
- prevalence
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Científica Latina A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hugo Mendieta Zerón, Asociación Científica Latina A.C.
- Investigators
- María del Socorro Camarillo Romero, PhD., Study chair, Autonomous University of the State of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886013
- Sponsor's protocol ID
- 2016-03
- Status last verified
- Aug 2016
- First submitted
- 21 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FTO rs9939609 and PPARy rs1801282 Polymorphisms in Mexican Adolescents With Overweight and Obesity at High Risk for Developing Diabetes
- ClinicalTrials.gov ID
- NCT02886013
- Acronym / sponsor ID
- 2016-03
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Keywords
- prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Asociación Científica Latina A.C.University, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Population 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), were invited to participate.
Anthropometry The body mass index (BMI) was calculated as weight (kg) divided by height (m) squared with conventional stadiometer; dividing the results in normal, overweight and obesity according to the classification of the World Health Organization (WHO), specifically for adolescents by gender and age.
Laboratory 3 mL of venous blood (Vacutainer tubes) were taken in fasting. The concentration of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides were determined by enzymatic methods (Randox Laboratories Ltd, County Antrim, UK); whereas leptin and adiponectin concentrations were determined by the immunosorbent assay (ELISA) (Invitrogen MR Frederyck MD USA). 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). After extraction, the DNA was quantified using a NanoPhotometer (Implen GmbH, Germany), reporting concentration (μg/ml) and purity (260/280 absorbance). Genotyping was performed by polymerase chain reaction (PCR) Life express thermal cycler (Bioer, China). The primers and conditions for each polymorphism are listed in Table 1.
The oligonucleotides were designed using the Primer Quest web tool (Integrated DNA Technologies, Inc., CA, USA) and synthesized at the Synthesis and DNA Sequencing Unit of the National Autonomous University of Mexico (UNAM) Institute of Biotechnology (Cuernavaca, Morelos, Mexico). A search was performed in BLAST to verify the correct hybridization. The final products were visualized in 2% agarose gels, stained with ethidium bromide, and visualized under an UV transilluminator (Gel Logic 212 Pro, Carestream, USA). To confirm the detection of polymorphisms sequencing was performed at the National Institute of Genomic Medicine (INMEGEN), Mexico City.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Mexican adolescents with overweight and obesity at high risk for developing diabetes.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Those with a history of smoking, pregnancy or diagnosed with a chronic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the FTO rs9939609 and PPARy rs1801282 polymorphisms.
Time frame: up to 24 months.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María del Socorro Camarillo Romero, PhD. study chair
Autonomous University of the State of Mexico
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Insulin Resistance, run by Asociación Científica Latina A.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the FTO rs9939609 and PPARy rs1801282 polymorphisms. (time frame: up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.