Examination of Cognitive Function in Obesity and Following Weight Loss
September 25, 2018 updated by: Vance L. Albaugh, MD, PhD, Vanderbilt University Medical Center
Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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).
|
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.
|
These are patients who will be starting a structured medical weight loss program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Repeated Measures Up to 6 Months
|
|
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.
|
Repeated Measures Up to 6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Repeated Measures Up to 6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Vance L Albaugh, MD, PhD, Vanderbilt University Medical Center
- Study Director: Naji N Abumrad, MD, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2018
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
July 1, 2020
Study Registration Dates
First Submitted
December 12, 2016
First Submitted That Met QC Criteria
December 14, 2016
First Posted (ESTIMATE)
December 15, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 27, 2018
Last Update Submitted That Met QC Criteria
September 25, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.