- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205318
FTO Gene Variants and Diet in Obesity
December 17, 2019 updated by: ZEHRA BUYUKTUNCER, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06100
- Zehra Buyuktuncer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
400 unrelated individuals, aged 24-50 years
Description
Inclusion Criteria:
- attending routine outpatient visits,
- aged 24 to 50 years,
- having a BMI ≥ 18.50 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
study
obese (BMI ≥25.00 kg/m2, n=200)
|
|
control
non-obese (BMI= 18.50-24.99
kg/m2, n=200)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Genetic analysis of two SNPs at FTO gene
Time Frame: up to 36 weeks
|
FTO SNPs rs9939609 and rs10163409
|
up to 36 weeks
|
|
Anthropometric measurements
Time Frame: up to 36 weeks
|
Body mass index, waist circumference, hip circumference, body composition
|
up to 36 weeks
|
|
Biochemical measurements
Time Frame: up to 36 weeks
|
lipid profile, glucose, insulin, adiponectin
|
up to 36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zehra Buyuktuncer, Hacettepe University, Department of Nutrition and Dietetics, Ankara, TURKEY
- Principal Investigator: Vimales Karani Santhanakrishnan, Department of Food and Nutritional Sciences, University of Reading, UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
July 21, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (Actual)
December 19, 2019
Study Record Updates
Last Update Posted (Actual)
December 19, 2019
Last Update Submitted That Met QC Criteria
December 17, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO15/612-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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