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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215888
• Other study ID #: MED-2017-25812
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: February 11, 2020

Study information

• Verified date: June 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Inflammation
• Insulin Resistance
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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