Clinical trial NCT03215888: Effects of Change in Insulin Resistance and Systemic Inflammation on Brain Structure and Function
Official title: Effects of Change in Insulin Resistance and Systemic Inflammation After Bariatric Surgery on Brain Neurochemistry, Neuroinflammation and Cognitive Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery Candidate
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese Group • Undergoing VSG-type bariatric surgery

Non-Obese Group-healthy controls

• BMI \< 25

Brief summary: Obesity is associated with alterations in brain structure and cognitive impairment and is a risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity related decline in cognitive function are not fully understood. The long-term goal of this project is to understand how obesity affects cognitive function, with the aim to develop new ways to prevent and treat obesity related cognitive decline

Detailed description: A growing body of evidence suggests that obesity is associated with alterations in brain structure and cognitive impairment. Mid-life obesity is a risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity related decline in cognitive function are not fully understood. The long-term goal of this research is to identify how obesity, insulin resistance (IR), and their treatment impact brain structure and function. The investigators propose that IR and obesity related inflammation are two modifiable factors that affect neuronal integrity and lead to cognitive dysfunction. In this proposal, investigators will test two hypotheses: 1) among obese patients planning to undergo bariatric surgery (specifically vertical sleeve gastrectomy), baseline IR and systemic and brain markers of inflammation will inversely correlate with performance on cognitive testing and correlate with abnormalities in brain structure and 2) following bariatric surgery subjects who experience the greatest reduction in IR and obesity related inflammation will have the greatest improvement in cognitive function and brain structure. To address these hypotheses, investigators will use a comprehensive battery of tests to evaluate cognition and state of the art magnetic resonance imaging (MRI) techniques to assess brain structure and neurochemistry before and six months after bariatric surgery.

Eligibility criteria: Inclusion Criteria:

Obese Group

* Undergoing VSG-type bariatric surgery
* BMI \> 30
* Current weight less than 400 lbs

Non-Obese Group

* Age 30-50
* BMI \< 25

Exclusion Criteria:

Both Groups

* History of type 1 or type 2 diabetes
* History of stroke
* History of epilepsy
* History of Neurosurgical procedures
* Past or current history of severe psychiatric illness
* Pass or current history of alcohol or substance abuse
* Absence of metallic substances in body or ability to remove before imaging procedure
* History of claustrophobia or known inability to tolerate MRI
* Inability to consent

Primary outcomes:
measure: Change insulin resistance and inflammatory markers
timeFrame: at baseline (before surgery) and 6 months post surgery
Secondary outcomes:
measure: change in neurocognitive function testing
timeFrame: at baseline (before surgery) and 6 months post surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Amir Moheet
role: PRINCIPAL_INVESTIGATOR
References: