Clinical trial NCT02994186: Examination of Cognitive Function in Obesity and Following Weight Loss
Official title: Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Bariatric Surgery Candidate
Weight Loss
Keywords: cognitive function
obesity
bariatric surgery
metabolic surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Lumos Labs, Inc.
First posted: 2016-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Cognitive Function Score
timeFrame: Repeated Measures Up to 6 Months
measure: Cognitive Function Score - Surgical Group Comparison
timeFrame: Repeated Measures Up to 6 Months
Secondary outcomes:
measure: Cognitive Function Score - Crossover Patients
timeFrame: Repeated Measures Up to 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Vance L Albaugh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Naji N Abumrad, MD
role: STUDY_DIRECTOR
References: