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Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption

U

University of Sao Paulo

Status

Completed

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02072694
CAAE - 0426.0.004.000-10 (Registry Identifier)
Process HCRP: 12241/2010

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups, including a placebo group

75 grams of glucose plus water solution
Experimental group
Description:
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.
Treatment:
Other: Pure water
Other: 75 grams of glucose plus water solution
Pure water.
Placebo Comparator group
Description:
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).
Treatment:
Other: Pure water
Other: 75 grams of glucose plus water solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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