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Clinical Trials/NCT03215888
NCT03215888
Completed
Not Applicable

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

University of Minnesota1 site in 1 country29 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Minnesota
Enrollment
29
Locations
1
Primary Endpoint
Change insulin resistance and inflammatory markers
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
February 11, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change insulin resistance and inflammatory markers

Time Frame: 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 Outcomes

  • change in neurocognitive function testing(at baseline (before surgery) and 6 months post surgery)

Study Sites (1)

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