Cognition and Magnetic Resonance Imaging of Brain Inflammation in Obesity (NIFOB)

The Washington University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Cognitive testing; Procedure: Magnetic resonance imaging; Procedure: Oral glucose tolerance test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04116229

201805053

P30DK020579 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Normal-weight

Active Comparator group

Description:

Participants who have a body mass index within the normal-weight category.

Treatment:

Procedure: Magnetic resonance imaging

Behavioral: Cognitive testing

Procedure: Oral glucose tolerance test

Obese

Active Comparator group

Description:

Participants who have a body mass index within the obese category.

Treatment:

Procedure: Magnetic resonance imaging

Behavioral: Cognitive testing

Procedure: Oral glucose tolerance test