Cerebrospinal Fluid Biomarkers in Bariatric Surgery
The goal of this project is to understand why bariatric surgery is such an effective treatment for obesity with a focus on brain mechanisms. Cerebrospinal fluid (CSF) neuropeptide, hormone and protein levels will be measured as a surrogate for changes in brain activity in participants before and after bariatric surgery as compared with participants before and after diet-induced weight loss. The investigators are studying neuropeptides and hormones that are know to be involved with the regulation of appetite and body weight to determine if some of the changes that are expected to occur after diet-induced weight loss do not occur after bariatric surgery. In addition, proteomic analysis will be used to uncover new protein biomarkers that are unique to surgical weight loss. The results of these studies will help explain why bariatric surgery is so effective in achieving long-term weight loss. Understanding how the central nervous system responds to bariatric surgery could help the development of alternative nonsurgical therapies for obesity and its metabolic complications.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 20 October 2020
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 1 January 2026
👥 Enrollment (Estimated) 48
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18-65 years old
    • * BMI 35-55

    Exclusion Criteria:

    • * No clinically significant medical conditions
    • * No use of tobacco
    • * No alcohol or drug abuse
    • * No recent weight change (+/-5%) within prior 6 months
    • * No medications that may affect body weight or blood glucose
    • * No diabetes medications, beta-blockers, opiates or glucocorticoids
    • * No pregnancy, breastfeeding, or planning to become pregnant during the study (diet group only)
    • * No lactose intolerance
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 April 2020
  • First Submitted that Met QC Criteria 16 April 2020
  • First Posted 17 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024