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N/A N=20 Double-blind Other

Cognition and Magnetic Resonance Imaging of Brain Inflammation in Obesity

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT04116229 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI) — .0468; .0492; .176; .186 unitless — p=0.28

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Oral glucose tolerance test (Procedure); Cognitive testing (Behavioral); Magnetic resonance imaging (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Oct 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI)		 .0468; .0492; .176; .186 0.28
PRIMARY
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		 60.3; 53.3; 54.4; 59.3 0.01 sig

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.

Eligibility Criteria

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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04116229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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