ObesityNCT02994186
Examination of Cognitive Function in Obesity and Following Weight Loss
An observational study of Obesity and Bariatric Surgery Candidate, run by Vanderbilt University Medical Center.
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". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Weight Loss
- What is being tested?
- Bariatric Surgery and Medical Weight Loss Program
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- English speaking
- Within the age rage of 18-70 years
- Able to give informed consent
Who cannot join
- 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
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- Any prior suicide attempt
- Revisional bariatric surgery
- Current or former tobacco user / smoker
- Currently pregnant
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Bariatric Surgery Candidate, Weight Loss
- Being tested
- Bariatric Surgery, Medical Weight Loss Program
- Keywords
- cognitive function, obesity, bariatric surgery, metabolic surgery
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.
Medical Weight Loss ProgramOther
These are patients who will be starting a structured medical weight loss program.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Bariatric Surgery | |
| Medical Weight Loss | Patients in this group are those who are being enrolled in a supervised medical weight loss program. Receives: Other: Medical Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Repeated Measures Up to 6 Months
Secondary outcomes (1)
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.
Measured: Repeated Measures Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start1 Jul 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lumos Labs, Inc.
- Responsible party
- Principal investigator, Vance L. Albaugh, MD, PhD, Vanderbilt University Medical Center
- Investigators
- Vance L Albaugh, MD, PhD, Principal investigator, Vanderbilt University Medical CenterNaji N Abumrad, MD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994186
- Sponsor's protocol ID
- 161918
- Status last verified
- Sep 2018
- First submitted
- 12 Dec 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT02994186
- Acronym / sponsor ID
- 161918
- Conditions
- Obesity, Bariatric Surgery Candidate, Weight Loss
- Keywords
- cognitive function, obesity, bariatric surgery, metabolic surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Lumos Labs, Inc.
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Weight Loss | – | Procedure: Bariatric SurgeryPatients in this group are those that will be undergoing bariatric surgery (either Roux-en-Y gastric bypass or vertical sleeve gastrectomy). |
| Medical Weight Loss | – | Other: Medical Weight Loss ProgramPatients in this group are those who are being enrolled in a supervised medical weight loss program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- English speaking
- Within the age rage of 18-70 years
- Able to give informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryThese are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass. | Procedure or surgery | Surgical Weight Loss |
| Medical Weight Loss ProgramThese are patients who will be starting a structured medical weight loss program. | Other | Medical Weight Loss |
Primary outcome
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.
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.
1 secondary outcome
Cognitive Function Score - Crossover Patients
Time frame: Repeated Measures Up to 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vance L Albaugh, MD, PhD principal investigator
Vanderbilt University Medical Center
Naji N Abumrad, MD study director
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function Score (time frame: Repeated Measures Up to 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.