Clinical trial NCT04116229: Cognition and Magnetic Resonance Imaging of Brain Inflammation in Obesity
Official title: Neuroinflammation in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Inflammation
Cognitive impairment
Neuroimaging
Magnetic resonance imaging
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study employed a single group model in which participants with obesity and participants with normal-weight underwent magnetic resonance imaging, blood draws and cognitive assessment.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Brain Inflammation Metrics in Obese and Normal-weight Individuals as Measured by Magnetic Resonance Image-based Diffusion Basis Spectrum Imaging (DBSI)
timeFrame: 1.5 hours at the end of one (up to) 8 hour study day that includes all outcome measures
measure: 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
timeFrame: 40 minutes during one (up to) 8 hour study day that includes all outcome measures; after OGTT and prior to MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tamara Hershey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
citation: Cross AH, Song SK. "A new imaging modality to non-invasively assess multiple sclerosis pathology". J Neuroimmunol. 2017 Mar 15;304:81-85. doi: 10.1016/j.jneuroim.2016.10.002. Epub 2016 Oct 8.
citation: Breda E, Cavaghan MK, Toffolo G, Polonsky KS, Cobelli C. Oral glucose tolerance test minimal model indexes of beta-cell function and insulin sensitivity. Diabetes. 2001 Jan;50(1):150-8. doi: 10.2337/diabetes.50.1.150.