Examination of Cognitive Function in Obesity and Following Weight Loss

NCT02994186 | Withdrawn

• 1 other identifier: 161918
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bariatric surgery is the most effective, long-term treatment for morbid obesity, and consistent with previous findings, individuals who lose significant weight after surgery also have improved cognition or "brain function". The mechanisms behind these cognitive improvements are currently unknown, but are the focus of much research effort. The goal of this pilot study is to thoroughly describe these changes in surgical versus medical weight loss patients over time in a repeated measures fashion.

Conditions

Obesity; Bariatric Surgery Candidate; Weight Loss

Keywords

cognitive function; obesity; bariatric surgery; metabolic surgery

Outcome Measures

Primary Outcomes (2)

• Cognitive Function Score

  Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program.

  Repeated Measures Up to 6 Months

• Cognitive Function Score - Surgical Group Comparison

  Within group and between group longitudinal measurements will be made using longitudinal regression methods. Baseline as well as 1, 3 and 6 month measurements will be captured either from the time of bariatric surgery or initiation of a supervised medical weight loss program. The bariatric operation will be included (Roux-en-Y gastric bypass vs. Vertical Sleeve Gastrectomy) as a variable in the regression model for between and within subjects comparisons in the bariatric surgery group.

  Repeated Measures Up to 6 Months

Secondary Outcomes (1)

• Cognitive Function Score - Crossover Patients

  Repeated Measures Up to 6 Months

Study Arms (2)

Surgical Weight Loss

Patients in this group are those that will be undergoing bariatric surgery (either Roux-en-Y gastric bypass or vertical sleeve gastrectomy).

Procedure: Bariatric Surgery

Medical Weight Loss

Patients in this group are those who are being enrolled in a supervised medical weight loss program.

Other: Medical Weight Loss Program

Interventions

Bariatric Surgery PROCEDURE

These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.

Surgical Weight Loss

Medical Weight Loss Program OTHER

These are patients who will be starting a structured medical weight loss program.

Medical Weight Loss

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that will be recruited for this study are those individuals that are pursuing either medical or surgical weight loss options at the Vanderbilt Centers for Medical and Surgical Weight Loss.

You may qualify if:

• English speaking
• Within the age rage of 18-70 years
• Able to give informed consent

You may not qualify if:

• Neurological disorder or previous injury (e.g. stoke, dementia, seizures, traumatic brain injury)
• History of any moderate to severe head injury (i.e. \>5 minutes of loss of consciousness)
• History of severe psychiatric illness requiring current pharmacologic therapy(e.g. schizophrenia, bipolar disorder, personality disorders)
• History of illicit drug or alcohol abuse
• Known diagnosis of learning or developmental disability
• Impaired sensory function
• Any prior suicide attempt
• Revisional bariatric surgery
• Current or former tobacco user / smoker
• Currently pregnant

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Lumos Labs, Inc.: collaborator

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Vance L Albaugh, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Naji N Abumrad, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow and Resident Surgeon

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 15, 2016
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share