Examination of Cognitive Function in Obesity and Following Weight Loss
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02994186|
Recruitment Status : Not yet recruiting
First Posted : December 15, 2016
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment|
|Obesity Bariatric Surgery Candidate Weight Loss||Procedure: Bariatric Surgery Other: Medical Weight Loss Program|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Longitudinal Assessment of Cognitive Function Following Bariatric Surgery or Medical Weight Loss Treatment|
|Estimated Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||July 2020|
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).
Procedure: Bariatric Surgery
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.
Other: Medical Weight Loss Program
These are patients who will be starting a structured medical weight loss program.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994186
|Contact: Vance L Albaugh, MD, PhDemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Vance L Albaugh, MD, PhD firstname.lastname@example.org|
|Contact: Naji N Abumrad, MD email@example.com|
|Principal Investigator: Vance L Albaugh, MD, PhD|
|Principal Investigator: Naji N Abumrad, MD|
|Sub-Investigator: Georgina Sellyn, BA|
|Principal Investigator:||Vance L Albaugh, MD, PhD||Vanderbilt University Medical Center|
|Study Director:||Naji N Abumrad, MD||Vanderbilt University Medical Center|