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

Completed

• Conditions: Obesity; Bariatric Surgery Candidate
• Interventions: Procedure: bariatric surgery

• Registration Number: NCT03215888
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-11-01
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese	bariatric surgery	Obese individuals undergoing bariatric surgery

Primary Outcome Measures

Name	Time	Method
Change insulin resistance and inflammatory markers	at baseline (before surgery) and 6 months post surgery	Change in insulin resistance and blood inflammatory markers from baseline (before surgery) and at 6 months post surgery

Secondary Outcome Measures

Name	Time	Method
change in neurocognitive function testing	at baseline (before surgery) and 6 months post surgery	changes in neurocognitive function testing from baseline (before surgery) and at 6 months post surgery

Trial Locations

Locations (1)

Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States