ObesityNCT04205318
FTO Gene Variants and Diet in Obesity
An observational study of Obesity and Diet Habit, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle… Read more about this study
- Who is it for?
- Ages 24 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diet Habit, Genetic Predisposition
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 31 Dec 2018
- 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 24 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 400 unrelated individuals, aged 24-50 years
Who may be able to join
- attending routine outpatient visits,
- aged 24 to 50 years,
- having a BMI ≥ 18.50 kg/m2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population
Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.
- Conditions
- Obesity, Diet Habit, Genetic Predisposition
- Keywords
- obesity, gene-diet interaction, FTO gene variant
- Medical subject headings
- Obesity, Feeding Behavior, Genetic Predisposition to Disease
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 |
|---|---|---|
| study | obese (BMI ≥25.00 kg/m2, n=200) | |
| control | non-obese (BMI= 18.50-24.99 kg/m2, n=200) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic analysis of two SNPs at FTO gene
FTO SNPs rs9939609 and rs10163409
Measured: up to 36 weeks
Anthropometric measurements
Body mass index, waist circumference, hip circumference, body composition
Measured: up to 36 weeks
Biochemical measurements
lipid profile, glucose, insulin, adiponectin
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Mar 2017
- Primary completion1 Feb 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, ZEHRA BUYUKTUNCER, Hacettepe University
- Investigators
- Zehra Buyuktuncer, Principal investigator, Hacettepe University, Department of Nutrition and Dietetics, Ankara, TURKEYVimales Karani Santhanakrishnan, Principal investigator, Department of Food and Nutritional Sciences, University of Reading, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205318
- Sponsor's protocol ID
- GO15/612-11
- Status last verified
- Aug 2019
- First submitted
- 21 Jul 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population
- ClinicalTrials.gov ID
- NCT04205318
- Acronym / sponsor ID
- GO15/612-11
- Conditions
- Obesity, Diet Habit, Genetic Predisposition
- Keywords
- obesity, gene-diet interaction, FTO gene variant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- University of Reading, The Scientific and Technological Research Council of Turkey
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Dec 2019 (actual)
- 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.
Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | – | –obese (BMI ≥25.00 kg/m2, n=200) |
| control | – | –non-obese (BMI= 18.50-24.99 kg/m2, n=200) |
Who may qualify
- Ages
- 24 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 400 unrelated individuals, aged 24-50 years
Key inclusion criteria (3 listed)
- attending routine outpatient visits,
- aged 24 to 50 years,
- having a BMI ≥ 18.50 kg/m2
Key exclusion criteria (0 listed)
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
Genetic analysis of two SNPs at FTO gene
Time frame: up to 36 weeks
FTO SNPs rs9939609 and rs10163409
Anthropometric measurements
Time frame: up to 36 weeks
Body mass index, waist circumference, hip circumference, body composition
Biochemical measurements
Time frame: up to 36 weeks
lipid profile, glucose, insulin, adiponectin
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 19 Dec 2019.
- 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.
Zehra Buyuktuncer principal investigator
Hacettepe University, Department of Nutrition and Dietetics, Ankara, TURKEY
Vimales Karani Santhanakrishnan principal investigator
Department of Food and Nutritional Sciences, University of Reading, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diet Habit, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 0 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 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Genetic analysis of two SNPs at FTO gene (time frame: up to 36 weeks). The study lists 3 primary outcomes in all. 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 19 Dec 2019.