NCT02598037

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

October 31, 2015

Last Update Submit

April 30, 2018

Conditions

Obesity

Keywords

ObesityPolymorphismHormones

Outcome Measures

Primary Outcomes (1)

  • Number of patients with or without polymorphism ih genes as determined by PCR

    Genotyping will be used to separate patients by genotypes.

    Three hours after the test meal

Secondary Outcomes (1)

  • Number of Participants With Abnormal Laboratory Values for hormones.

    Three hours after the test meal

Study Arms (1)

FTO gene polymorphism

OTHER

test meal after fasting for 12 hours

Dietary Supplement: Test meal

Interventions

Test mealDIETARY_SUPPLEMENT

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.

FTO gene polymorphism

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult women with grade 3 obesity.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro - CCS

Rio de Janeiro, 21941-590, Brazil

Location

Related Publications (9)

  • Brennan IM, Luscombe-Marsh ND, Seimon RV, Otto B, Horowitz M, Wishart JM, Feinle-Bisset C. Effects of fat, protein, and carbohydrate and protein load on appetite, plasma cholecystokinin, peptide YY, and ghrelin, and energy intake in lean and obese men. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G129-40. doi: 10.1152/ajpgi.00478.2011. Epub 2012 May 3.

    PMID: 22556143BACKGROUND

  • Deram S, Villares SM. Genetic variants influencing effectiveness of weight loss strategies. Arq Bras Endocrinol Metabol. 2009 Mar;53(2):129-38. doi: 10.1590/s0004-27302009000200003.

    PMID: 19466204BACKGROUND

  • Druce MR, Wren AM, Park AJ, Milton JE, Patterson M, Frost G, Ghatei MA, Small C, Bloom SR. Ghrelin increases food intake in obese as well as lean subjects. Int J Obes (Lond). 2005 Sep;29(9):1130-6. doi: 10.1038/sj.ijo.0803001.

    PMID: 15917842BACKGROUND

  • Erdmann J, Topsch R, Lippl F, Gussmann P, Schusdziarra V. Postprandial response of plasma ghrelin levels to various test meals in relation to food intake, plasma insulin, and glucose. J Clin Endocrinol Metab. 2004 Jun;89(6):3048-54. doi: 10.1210/jc.2003-031610.

    PMID: 15181097BACKGROUND

  • Frayling TM, Timpson NJ, Weedon MN, Zeggini E, Freathy RM, Lindgren CM, Perry JR, Elliott KS, Lango H, Rayner NW, Shields B, Harries LW, Barrett JC, Ellard S, Groves CJ, Knight B, Patch AM, Ness AR, Ebrahim S, Lawlor DA, Ring SM, Ben-Shlomo Y, Jarvelin MR, Sovio U, Bennett AJ, Melzer D, Ferrucci L, Loos RJ, Barroso I, Wareham NJ, Karpe F, Owen KR, Cardon LR, Walker M, Hitman GA, Palmer CN, Doney AS, Morris AD, Smith GD, Hattersley AT, McCarthy MI. A common variant in the FTO gene is associated with body mass index and predisposes to childhood and adult obesity. Science. 2007 May 11;316(5826):889-94. doi: 10.1126/science.1141634. Epub 2007 Apr 12.

    PMID: 17434869BACKGROUND

  • Haupt A, Thamer C, Staiger H, Tschritter O, Kirchhoff K, Machicao F, Haring HU, Stefan N, Fritsche A. Variation in the FTO gene influences food intake but not energy expenditure. Exp Clin Endocrinol Diabetes. 2009 Apr;117(4):194-7. doi: 10.1055/s-0028-1087176. Epub 2008 Dec 3.

    PMID: 19053021BACKGROUND

  • Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15.

    PMID: 23867619BACKGROUND

  • Loos RJ, Bouchard C. Obesity--is it a genetic disorder? J Intern Med. 2003 Nov;254(5):401-25. doi: 10.1046/j.1365-2796.2003.01242.x.

    PMID: 14535962BACKGROUND

  • Chen LP, Thomas EK, Hu SL, Hellstrom I, Hellstrom KE. Human papillomavirus type 16 nucleoprotein E7 is a tumor rejection antigen. Proc Natl Acad Sci U S A. 1991 Jan 1;88(1):110-4. doi: 10.1073/pnas.88.1.110.

    PMID: 1846033BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fernanda CM Magno, MSc

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 31, 2015

First Posted

November 5, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)