- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02072694
Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption
Cerebral Perfusion Changes in Obese Subjects After Administration of 75 Grams of Glucose. A SPECT, Controlled, Blinded and Randomized Study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Sao Paulo
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Ribeirão Preto, Sao Paulo, Brazil, 14091210
- Clinical Hospital of Ribeirao Preto
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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. |
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:
Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
|
PLACEBO_COMPARATOR: 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). |
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:
Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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30 minutes after a meal challenge (time of radiopharmaceutical injection)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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).
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30 minutes before, at the time and 30, 60 and 90 minutes after the radiopharmaceutical injection.
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Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
Time Frame: 6 hours before SPECT acquisition.
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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.
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6 hours before SPECT acquisition.
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Process HCRP: 12241/2010
- CAAE - 0426.0.004.000-10 (REGISTRY: Sistema Nacional de Informações sobre Ética em Pesquisa)
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