Association Between the Change of the Genes With Hormones and Food Consumption of Obese

April 30, 2018 updated by: Fernanda Cristina Carvalho Mattos Magno, Universidade Federal do Rio de Janeiro

Association Between the Change of the Genes With the Hormones and Food Consumption of Obese

Obesity is considered one of the most troubling chronic diseases for public health because of its rapid growth in the population. Many are the causal factors of this epidemic, and in recent years studies suggest the involvement of genetic factors in the etiology of obesity as a risk factor for its development. Polymorphism of the FTO gene is being studied in the past eight years and has been indicated as a predictor of obesity in the population, as well as associations in food intake, raising the possibility of influence in the regulation of hunger and satiety. Accordingly, researchers observed changes in levels of postprandial leptin and ghrelin, which can promote appetite and change the quantity and quality of food intake in subjects with the polymorphism FTO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a chronic disease with high growth in the world population, as well as being a risk factor for the development of other chronic diseases. Additionally, it is known that it is a multifactorial disease and polygenic, making it difficult to control. It is also recognized that some environmental factors, with emphasis on diet, can modulate the expression of certain genes and may help control obesity.

In recent decades, researchers from several countries has been devoted to studies that aim to propose alternatives for the treatment of obesity, emphasizing the regulation of energy balance and changes in lifestyle (diet and exercise), and try to clarify the reason some individuals more susceptible to these factors than other, favoring the body weight gain. These differences may be explained in part, by genetic factors.

The FTO gene has been considered a strong candidate gene for obesity because of its relation to the secretion of ghrelin, an important orexigenic hormone involved in the regulation of food intake, which could open new perspectives for studies of gene-environment interactions in obesity.

Considering the significant increase of obesity in the world population, it is understood that studies assessing environmental factors - particularly diet - and genes and genetic variants associated with obesity - may represent a major breakthrough in understanding the development of this disease, providing tools to propose possible changes in current dietary prescriptions for this population.

Also highlighted the lack of studies on the subject, which makes this proposal is innovative and unprecedented as it aims to evaluate the relationship between the FTO gene polymorphism with ghrelin secretion and food intake in obese.

It is suggested that obese individuals with a polymorphism in the FTO gene present higher serum concentrations of basal ghrelin and postprandial (after-fat meal), and the usual food intake, as well as the postprandial appetite, are associated with the concentrations basal and postprandial ghrelin, respectively. These results may generate data for changes in dietary prescriptions aimed at reducing the secretion and, or sensitivity to the hormone to control energy intake, whereas the individual's genotype can not be changed voluntarily in the current state of the art.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

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

  • Brazil
      • Rio de Janeiro, Brazil, 21941-590
        • Federal University of Rio de Janeiro - CCS

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult women with grade 3 obesity.

Exclusion Criteria:

  • Pregnant women, teenagers, elderly, use of corticosteroids, medicines for weight loss, bariatric surgery and affected by chronic diseases, such as hyperthyroidism or hypothyroidism, nephropathy, neuropathy, and inflammatory bowel disease. Also excluded are volunteers who do not fulfill all stages of the study.

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FTO gene polymorphism
test meal after fasting for 12 hours
Dietary supplement: Test meal
The test meal will contain the following features: 50% carbohydrate, 20% protein and 30% of total fat, and will be admnistrada after drawing blood fasting for 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with or without polymorphism ih genes as determined by PCR
Time Frame: Three hours after the test meal
Genotyping will be used to separate patients by genotypes.
Three hours after the test meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Abnormal Laboratory Values for hormones.
Time Frame: Three hours after the test meal
The hormonal analysis performed by the luminex method will be performed to evaluate the release of hormones between the genotypes.
Three hours after the test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Fernanda CM Magno, MSc, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 31, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31573114.1.0000.5257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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