Effects of Change in Insulin Resistance and Systemic Inflammation on Brain Structure and Function

Effects of Change in Insulin Resistance and Systemic Inflammation After Bariatric Surgery on Brain Neurochemistry, Neuroinflammation and Cognitive Function

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

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: bariatric surgery

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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Obese Group • Undergoing VSG-type bariatric surgery

Non-Obese Group-healthy controls

• BMI < 25

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese; Obese individuals undergoing bariatric surgery	Procedure: bariatric surgery; Obese patients will undergo brain imaging, neurocognitive function testing and measurement of insulin resistance and inflammatory markers pre- and post bariatric surgery
controls; matched non-obese controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change insulin resistance and inflammatory markers	Change in insulin resistance and blood inflammatory markers from baseline (before surgery) and at 6 months post surgery	at baseline (before surgery) and 6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in neurocognitive function testing	changes in neurocognitive function testing from baseline (before surgery) and at 6 months post surgery	at baseline (before surgery) and 6 months post surgery

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Amir Moheet, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): February 11, 2020

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Inflammation; Insulin Resistance
• Other Study ID Numbers: MED-2017-25812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No