Clinical trial NCT02079116: Ingestion of Lipids and Changes in Cerebral Blood Flow of People With Obesity
Official title: Acute Ingestion of Lipids and Alteration of Cerebral Perfusion in Obese Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lipids
Single Photon Emission Computed Tomography
Functional Neuroimaging
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-03-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat.


Eligibility criteria: Inclusion Criteria:

* Live in Ribeirão Preto, São Paulo - Brazil.
* 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.

Primary outcomes:
measure: Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.
timeFrame: 60 minutes after a meal challenge (time of radiopharmaceutical injection)
Secondary outcomes:
measure: 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.
timeFrame: 60 and 30 minutes before, at the time and 30 and 60 minutes after the radiopharmaceutical injection.
measure: Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
timeFrame: 6 hours before SPECT acquisition.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinical Hospital of Ribeirao Preto
state: Sao Paulo
Study officials:
affiliation: Ribeirão Preto Medical School. São Paulo University (USP)
name: Júlio S Marchini, Ph.D
role: PRINCIPAL_INVESTIGATOR
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