Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption

NCT ID: NCT02072694

Last Updated: 2014-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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75 grams of glucose plus water solution

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.

Group Type EXPERIMENTAL

75 grams of glucose plus water solution

Intervention Type OTHER

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.

Pure water

Intervention Type OTHER

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.

Pure water.

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).

Group Type PLACEBO_COMPARATOR

75 grams of glucose plus water solution

Intervention Type OTHER

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.

Pure water

Intervention Type OTHER

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.

Interventions

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75 grams of glucose plus water solution

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.

Intervention Type OTHER

Pure water

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Julio Sergio Marchini

Full Professor of Internal Medicine Department at Ribeirão Preto Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Júlio S Marchini, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ribeirão Preto Medical School. São Paulo University (USP)

Locations

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Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 16876568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18945945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15630408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19323780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14649373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15627585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10480611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12921877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17483007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11380575 (View on PubMed)

Related Links

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http://portal2.saude.gov.br/sisnep/extrato_projeto.cfm?codigo=369688

Record in the National Committee of Ethics in Research

Other Identifiers

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CAAE - 0426.0.004.000-10

Identifier Type: REGISTRY

Identifier Source: secondary_id

Process HCRP: 12241/2010

Identifier Type: -

Identifier Source: org_study_id

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