An observational study in Obesity, Bariatric Surgery Candidate and Weight Loss, sponsored by Vanderbilt University Medical Center. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by Vanderbilt University Medical Center · Observational
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.
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.
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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.
Exclusion Criteria:
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
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 having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.
These are patients who will be starting a structured medical weight loss program.
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.
Time frame: 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.
Time frame: Repeated Measures Up to 6 Months
Cognitive Function Score - Crossover Patients
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.
Time frame: Repeated Measures Up to 6 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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