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

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT03215888

Collaborator

(none)

Enrollment

Location

27.3

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Bariatric Surgery Candidate	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 Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Feb 11, 2020

Actual Study Completion Date :

Feb 11, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Amir Moheet, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT03215888

Other Study ID Numbers:

MED-2017-25812

First Posted:

Jul 12, 2017

Last Update Posted:

Jul 2, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Insulin Resistance

Inflammation

Study Results

No Results Posted as of Jul 2, 2021