NCT02072694

Brief Summary

This study evaluates the hypothesis that a meal constituted of only glucose produces differences in the brain blood flow in people with obesity that are not observed in people without obesity. These changes, at least in part, could explain the mechanisms involved in maintenance or development of obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

February 22, 2014

Last Update Submit

May 13, 2014

Conditions

Obesity

Keywords

ObesitySingle Photon Emission Computed TomographyFunctional Neuroimaging

Outcome Measures

Primary Outcomes (1)

  • Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.

    Using 99m technetium ecd radiopharmaceutical, this study aims to detect rCBF differences between SPECT images performed after a meal challenge composed by 75 grams of glucose and water and also after a challenge constituted by only water (control), both ingested orally. This approach is performed in a group of 10 people with obesity and also in 10 people without obesity.

    30 minutes after a meal challenge (time of radiopharmaceutical injection)

Secondary Outcomes (2)

  • Blood levels mean differences within both groups, with and without obesity and across these groups, of hormones and metabolites by multiplexed assay using luminex technology and spectrophotometry, respectively.

    30 minutes before, at the time and 30, 60 and 90 minutes after the radiopharmaceutical injection.

  • Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.

    6 hours before SPECT acquisition.

Study Arms (2)

75 grams of glucose plus water solution

EXPERIMENTAL

In the group with 10 volunteers with obesity, some of them are submitted first to the 75 grams of glucose plus water solution (meal challenge) and in another time to only water. Also, in the group with 10 volunteers without obesity, some of them are submitted first to the 75 grams of glucose plus water solution (meal challenge) and in another time to only water.

Other: 75 grams of glucose plus water solutionOther: Pure water

Pure water.

PLACEBO COMPARATOR

In the same group with 10 volunteers with obesity, some of them are submitted first to only water (control) and in another time to the 75 grams of glucose plus water solution (meal challenge). Also, in the same group with 10 volunteers without obesity, some of them are submitted first to only water (control) and in another time to the 75 grams of glucose plus water solution (meal challenge).

Other: 75 grams of glucose plus water solutionOther: Pure water

Interventions

75 grams of glucose plus water solutionOTHER

A solution composed by 75 grams of glucose and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow: * 300 mL final volume of the solution. * Time of oral ingestion inferior than 2 minutes. * 30 minutes before the radiopharmaceutical injection. * 12 hours fasting minimum.

75 grams of glucose plus water solutionPure water.
Pure waterOTHER

Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow: * 300 mL final volume of the solution. * Time of oral ingestion inferior than 2 minutes. * 30 minutes before the radiopharmaceutical injection. * 12 hours fasting minimum.

75 grams of glucose plus water solutionPure water.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Live in Ribeirão Preto, São Paulo - Brazil.
  • Age between 18 and 40 years old.
  • Female gender.
  • Regular menses.
  • Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
  • BMI between 18,5 and 24,9 kg/m2, for the group without obesity.

You may not qualify if:

  • High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.
  • Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
  • Pregnancy or desire to be pregnant
  • Use of medications, excluding contraceptives.
  • Contraindication for magnetic resonance imaging.
  • Be in treatment for obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14091210, Brazil

Location

Related Publications (10)

  • Goldstone AP. The hypothalamus, hormones, and hunger: alterations in human obesity and illness. Prog Brain Res. 2006;153:57-73. doi: 10.1016/S0079-6123(06)53003-1.

    PMID: 16876568BACKGROUND

  • Figlewicz DP, Benoit SC. Insulin, leptin, and food reward: update 2008. Am J Physiol Regul Integr Comp Physiol. 2009 Jan;296(1):R9-R19. doi: 10.1152/ajpregu.90725.2008. Epub 2008 Oct 22.

    PMID: 18945945BACKGROUND

  • Kishi T, Elmquist JK. Body weight is regulated by the brain: a link between feeding and emotion. Mol Psychiatry. 2005 Feb;10(2):132-46. doi: 10.1038/sj.mp.4001638.

    PMID: 15630408BACKGROUND

  • Yun JW, Cho YK, Park JH, Kim HJ, Park DI, Sohn CI, Jeon WK, Kim BI. Abnormal glucose tolerance in young male patients with nonalcoholic fatty liver disease. Liver Int. 2009 Apr;29(4):525-9. doi: 10.1111/j.1478-3231.2008.01920.x.

    PMID: 19323780BACKGROUND

  • Tataranni PA, DelParigi A. Functional neuroimaging: a new generation of human brain studies in obesity research. Obes Rev. 2003 Nov;4(4):229-38. doi: 10.1046/j.1467-789x.2003.00111.x.

    PMID: 14649373BACKGROUND

  • DelParigi A, Chen K, Salbe AD, Reiman EM, Tataranni PA. Sensory experience of food and obesity: a positron emission tomography study of the brain regions affected by tasting a liquid meal after a prolonged fast. Neuroimage. 2005 Jan 15;24(2):436-43. doi: 10.1016/j.neuroimage.2004.08.035.

    PMID: 15627585BACKGROUND

  • Matsuda M, Liu Y, Mahankali S, Pu Y, Mahankali A, Wang J, DeFronzo RA, Fox PT, Gao JH. Altered hypothalamic function in response to glucose ingestion in obese humans. Diabetes. 1999 Sep;48(9):1801-6. doi: 10.2337/diabetes.48.9.1801.

    PMID: 10480611BACKGROUND

  • Suen VM, Silva GA, Tannus AF, Unamuno MR, Marchini JS. Effect of hypocaloric meals with different macronutrient compositions on energy metabolism and lung function in obese women. Nutrition. 2003 Sep;19(9):703-7. doi: 10.1016/s0899-9007(03)00104-7.

    PMID: 12921877BACKGROUND

  • Nonino-Borges CB, Martins Borges R, Bavaresco M, Suen VM, Moreira AC, Marchini JS. Influence of meal time on salivary circadian cortisol rhythms and weight loss in obese women. Nutrition. 2007 May;23(5):385-91. doi: 10.1016/j.nut.2007.02.007.

    PMID: 17483007BACKGROUND

  • Wichert-Ana L, Velasco TR, Terra-Bustamante VC, Araujo D Jr, Junior VA, Kato M, Leite JP, Assirati JA, MacHado HR, Bastos AC, Sakamoto AC. Typical and atypical perfusion patterns in periictal SPECT of patients with unilateral temporal lobe epilepsy. Epilepsia. 2001 May;42(5):660-6. doi: 10.1046/j.1528-1157.2001.41900.x.

    PMID: 11380575BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Júlio S Marchini, Ph.D

    Ribeirão Preto Medical School. São Paulo University (USP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Internal Medicine Department at Ribeirão Preto Medical School

Study Record Dates

First Submitted

February 22, 2014

First Posted

February 26, 2014

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

BR(1)