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OpenTrials
Completed

NCT Number: NCT03215888

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

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Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Obese patients will undergo brain imaging, neurocognitive function testing and measurement of insulin resistance and inflammatory markers pre- and post bariatric surgery

Primary outcomes

  1. 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

  1. change in neurocognitive function testing

    Time frame: at baseline (before surgery) and 6 months post surgery

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2017
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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