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Examination of Cognitive Function in Obesity and Following Weight Loss

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ClinicalTrials.gov Identifier: NCT02994186
Recruitment Status : Not yet recruiting
First Posted : December 15, 2016
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Lumos Labs, Inc.
Information provided by (Responsible Party):
Vance L. Albaugh, MD, PhD, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Obesity Bariatric Surgery Candidate Weight Loss Procedure: Bariatric Surgery Other: Medical Weight Loss Program

Detailed Description:
Recent studies have demonstrated that obesity is associated with decreased cognitive function and, interestingly, weight loss is associated with improved cognitive function. Bariatric surgery is the most effective, long-term treatment for morbid obesity, and consistent with these previous findings, individuals who lose significant weight after surgery appear to have improved cognition. Previous results have only reported the appearance of cognitive improvements starting at three months postoperatively, thus, the main focus of this study is to discover whether cognitive function improvements are seen as early as one month after bariatric surgery. An acceleration in the onset of cognitive function changes could provide insight towards the ambiguous underlying neural mechanisms. The benefits of bariatric surgery extend beyond reversible cognitive deficits. Many of the medical comorbid conditions that these patients have before surgery (e.g. high blood pressure, high cholesterol, diabetes) typically resolve prior to any significant weight loss. The mechanisms for these weight-independent improvements are also undetermined. A secondary focus of this study is to determine whether or not cognitive function following bariatric surgery also improves prior to significant weight loss. To test whether cognitive function changes following bariatric surgery, two cohorts of surgical patients will be recruited as well as another group of patients undergoing medical weight loss treatment. The goal of this pilot study is to reproduce and expand upon previous findings that demonstrate cognitive improvements following bariatric surgery.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.

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




Primary Outcome Measures :
  1. Cognitive Function Score [ Time Frame: Repeated Measures Up to 6 Months ]
    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.

  2. Cognitive Function Score - Surgical Group Comparison [ Time Frame: Repeated Measures Up to 6 Months ]
    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.


Secondary Outcome Measures :
  1. Cognitive Function Score - Crossover Patients [ Time Frame: Repeated Measures Up to 6 Months ]
    There will be a group of patients that will crossover at 6 months from the medical weight loss group to the surgical weight loss group. The cognitive function score in these patients will be compared between treatment groups, as they will effectively be represented in each group.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994186


Contacts
Contact: Vance L Albaugh, MD, PhD 615-322-5000 vance.albaugh@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Vance L Albaugh, MD, PhD       vance.albaugh@vanderbilt.edu   
Contact: Naji N Abumrad, MD       naji.abumrad@vanderbilt.edu   
Principal Investigator: Vance L Albaugh, MD, PhD         
Principal Investigator: Naji N Abumrad, MD         
Sub-Investigator: Georgina Sellyn, BA         
Sponsors and Collaborators
Vanderbilt University Medical Center
Lumos Labs, Inc.
Investigators
Principal Investigator: Vance L Albaugh, MD, PhD Vanderbilt University Medical Center
Study Director: Naji N Abumrad, MD Vanderbilt University Medical Center

Responsible Party: Vance L. Albaugh, MD, PhD, Postdoctoral Fellow and Resident Surgeon, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02994186     History of Changes
Other Study ID Numbers: 161918
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vance L. Albaugh, MD, PhD, Vanderbilt University Medical Center:
cognitive function
obesity
bariatric surgery
metabolic surgery

Additional relevant MeSH terms:
Obesity
Body Weight
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Body Weight Changes