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Completed

NCT Number: NCT02137070

The WISE (Weightloss Intervention Surgical Effects) Brain Study

This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.

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Key information

Conditions

Diabetes Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss Weightloss

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida - College of Public Health and Health Professions

Gainesville, Florida, 32611, United States

About this study

There will be two groups of people studied:

One group has chosen (independently of this research study) to have weight loss surgery to help them lose weight.

Another group will not choose to have any weight loss surgery. All research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will have an MRI Brain Scan at those same times also to look at 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index >35
  • Diabetes or no diabetes
  • Compatible with MRI Scanning
  • Willing to give a small blood sample on 3 occasions
  • Capable of providing informed consent

Exclusion criteria

  • Prior neurological disorder
  • Mini Mental Status Exam score
  • Major psychiatric disturbance (schizophrenia, chronic intractable depression,
  • Coronary revascularization, peripheral vascular disease
  • Severe cardio vascular disease history
  • Unstable medical conditions (cancer)

Treatment and study plan

Bariatric Surgery Candidates

Procedure

Participants who are intending to have bariatric surgery for weight loss

Non surgical/Community volunteers

Other

Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss

Primary outcomes

  1. Change in BOLD fMRI Signal

    Time frame: Change from baseline at 18 months

    Brain activation changes will change in the frontal cortex and hippocampus.

    • z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions
    • a value of < 0 suggests a weakening of the connections between brain areas; and a value of > 0 suggests a strengthening of the connections between brain areas
    • A value of r=0 indicates that two brain regions were functionally disconnected

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function

Acronym: WISEBrain

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
May 13, 2014
Registry last updated
Dec 5, 2024

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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