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Completed

NCT Number: NCT02072694

Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14091210, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

75 grams of glucose plus water solution

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

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.

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.

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

    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.

Secondary outcomes

  1. 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.

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

    This study looks for mean differences of blood levels within and across groups with and without obesity. The metabolites and hormones/cytokines measured are, respectively: glucose (measured by spectrophotometry), insulin, leptin, amylin, interleukin 6 (IL-6), tumor necrosis factor alpha, active ghrelin, peptide yy (PYY) and pancreatic polypeptide (PP) (multiplexed assay using luminex).

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

    Time frame: 6 hours before SPECT acquisition.

    This study also aims to measure and compare the REE by indirect calorimetry with a Quark (Cosmed, Italy) calorimeter and the body composition by Byodinamics 450 (Biodynamics Corp., United States) within the two groups and across them.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Cerebral Perfusion Changes in Obese Subjects After Administration of 75 Grams of Glucose. A SPECT, Controlled, Blinded and Randomized Study.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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