Cognition and Magnetic Resonance Imaging of Brain Inflammation in Obesity

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Oral glucose tolerance test; Behavioral: Cognitive testing; Procedure: Magnetic resonance imaging

• Registration Number: NCT04116229
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The rate of obesity in the United States is high and is a risk factor for concurrent cognitive impairment and, in late life, dementias such as Alzheimer's disease. In order to prevent or reduce cognitive impairment, the mechanism underlying the link between obesity and cognitive impairment must be understood. The current study aims to provide preliminary data on whether brain inflammation occurs in obesity and relates to cognitive deficits using magnetic resonance neuroimaging and cognitive testing. It is hypothesized that obese individuals will have greater brain inflammation and lower cognitive function compared to normal-weight individuals. Further, it is predicted that brain inflammation will relate to cognitive function and plasma indicators of inflammation in obese individuals.

Detailed Description

Initially, normal-weight or obese potential participants are screened by a phone interview that assesses medical history. Obtainment of informed consent and further screening occurs on the day of the study visit. Participants then undergo a 2 hour oral glucose tolerance test (OGTT) including blood draws for metabolic and inflammatory marker levels in plasma. Lunch is then provided. Participants are then administered 30 minute computer-based cognitive testing from the NIH Toolbox Cognition Battery. After cognitive testing, participants undergo 1.5 hour magnetic resonance imaging (MRI) that includes structural, diffusion tensor, and functional MR imaging.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-19
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Results First Submitted: 2022-07-14
• Results First Submitted QC: 2022-09-27
• Results First Posted: 2022-10-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Non-obese (body mass index = 18 - 25 kg/m^2) or Obese (body mass index ≥ 30 kg/m^2
• Any race or ethnicity
• Native English speaker

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Exclusion Criteria

• Past or current diabetes
• Current psychotropic medication use
• Past or current neurological illness
• Past or current substance or alcohol misuse
• Past or current mental illness
• Current binge eating disorder
• Magnetic resonance imaging contraindications
• Pregnancy
• Currently lactating
• Tobacco use within past month
• Over 350 lb

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal-weight	Cognitive testing	Participants who have a body mass index within the normal-weight category.
Obese	Cognitive testing	Participants who have a body mass index within the obese category.
Normal-weight	Oral glucose tolerance test	Participants who have a body mass index within the normal-weight category.
Normal-weight	Magnetic resonance imaging	Participants who have a body mass index within the normal-weight category.
Obese	Oral glucose tolerance test	Participants who have a body mass index within the obese category.
Obese	Magnetic resonance imaging	Participants who have a body mass index within the obese category.

Primary Outcome Measures

Name	Time	Method
Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI)	1.5 hours at the end of one (up to) 8 hour study day that includes all outcome measures	Diffusion Basis Spectrum Imaging (Cross and Song, 2017) is a computational method that will be applied to diffusion tensor images of the brain to estimate putative inflammation-related markers including cellularity and edema in obese and normal-weight individuals. DBSI metrics are quantitative but unitless. Cellularity and edema fractions of the total diffusion signal (including axial, radial, restricted (cellularity) and hindered (edema)) will be estimated in brain white matter tracts.
Cognitive Function in Obese and Normal-weight Individuals as Measured by the National Institutes of Health (NIH) Toolbox Cognitive Battery and DBSI Putative Neuroinflammation Metrics	40 minutes during one (up to) 8 hour study day that includes all outcome measures; after OGTT and prior to MRI	Cognitive performance including fluid and crystallized cognition composite T-scores from computer-based NIH Cognitive Toolbox assessments (Weintraub et al., 2013) will be assessed in obese and normal-weight individuals. These T-scores will include scores from tasks that assess attention and executive functioning, episodic memory, working memory, language, processing speed, and immediate recall (see NIH Toolbox Cognitive Battery website). T-scores are corrected for socioeconomic status and their distribution has a mean of 50 and a standard deviation of 10. Higher T-scores indicate better cognitive function. T-scores will be correlated with DBSI-assessed neuroinflammation metrics including restricted fraction (DBSI RF, putative cellularity) and hindered fraction (DBSI HF, putative vasogenic edema) in brain white matter tracts.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States