Examination of Cognitive Function in Obesity and Following Weight Loss

Obesity Clinical Trial

Official title:

Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02994186
• Other study ID #: 161918
• Status: Withdrawn
• Start date: July 1, 2018
• Est. completion date: July 2020

Study information

• Verified date: September 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Body Weight
• Obesity
• Weight Loss

Intervention

Procedure:
• Bariatric Surgery
These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.

Other:
• Medical Weight Loss Program
These are patients who will be starting a structured medical weight loss program.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Lumos Labs, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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