NCT04205318

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

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

March 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
Last Updated

December 19, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

July 21, 2019

Last Update Submit

December 17, 2019

Conditions

ObesityDiet HabitGenetic Predisposition

Keywords

obesitygene-diet interactionFTO gene variant

Outcome Measures

Primary Outcomes (3)

  • Genetic analysis of two SNPs at FTO gene

    FTO SNPs rs9939609 and rs10163409

    up to 36 weeks

  • Anthropometric measurements

    Body mass index, waist circumference, hip circumference, body composition

    up to 36 weeks

  • Biochemical measurements

    lipid profile, glucose, insulin, adiponectin

    up to 36 weeks

Study Arms (2)

study

obese (BMI ≥25.00 kg/m2, n=200)

control

non-obese (BMI= 18.50-24.99 kg/m2, n=200)

Eligibility Criteria

Age24 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

400 unrelated individuals, aged 24-50 years

You may qualify if:

  • attending routine outpatient visits,
  • aged 24 to 50 years,
  • having a BMI ≥ 18.50 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zehra Buyuktuncer

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityFeeding BehaviorGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorDisease SusceptibilityDisease AttributesPathologic Processes

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2019

First Posted

December 19, 2019

Study Start

March 1, 2017

Primary Completion

February 1, 2018

Study Completion

December 31, 2018

Last Updated

December 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)