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| Name | Class |
|---|---|
| Lumos Labs, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Medical Weight Loss | Patients in this group are those who are being enrolled in a supervised medical weight loss program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric Surgery | Procedure | These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Repeated Measures Up to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Vance L Albaugh, MD, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Naji N Abumrad, MD | Vanderbilt University Medical Center | Study Director |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Medical Weight Loss Program | Other | These are patients who will be starting a structured medical weight loss program. |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |