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WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Recruiting
20-75 years
All
Phase N/A

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Overview

The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery.

Description

There will be one group of study participants.

The group will (independently of this research study) have weight loss surgery to help them with weight loss.

All research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will also undergo a non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention days post-surgery, for 30 days at home with the device that is provided.

The group will have an MRI Brain Scan at each time-point to study the changes in the structure and function of the brain tissue.

Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.

Eligibility

Inclusion Criteria:

  • Between age: 20-75 yrs, English speaking, Physically mobile
  • Body Mass Index (BMI) >35 kg before surgery
  • Compatible of MRI Scanning
  • Willing to give a small blood sample
  • Capable of providing informed consent

Exclusion Criteria:

  • Prior or current neurological disorder
  • Major psychiatric disturbance
  • Unstable medical conditions (cancer)
  • MRI contraindications (claustrophobia, metal implants, waist/torso circumference)

Study details
    Diabetes
    Weight Loss

NCT06861790

University of Florida

1 November 2025

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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