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

NCT03215888 | Completed

• 1 other identifier: MED-2017-25812
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in neurocognitive function testing

  at baseline (before surgery) and 6 months post surgery

Study Arms (2)

Obese

Obese individuals undergoing bariatric surgery

Procedure: bariatric surgery

controls

matched non-obese controls

Interventions

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

Obese

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Obese Group • Undergoing VSG-type bariatric surgery Non-Obese Group-healthy controls • BMI \< 25

You may qualify if:

• Obese Group
• Undergoing VSG-type bariatric surgery
• BMI \> 30
• Current weight less than 400 lbs
• Non-Obese Group
• Age 30-50
• BMI \< 25

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

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

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample to measure hormones and inflammatory markers

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Amir Moheet

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 12, 2017
• Study Start: November 1, 2017
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)