Understanding brain changes after bariatric surgery for obesity
Changes in Cerebrospinal Fluid Biomarkers After Bariatric Surgery
NA · Columbia University · NCT04350892
This study is trying to see how bariatric surgery affects brain chemicals that control appetite and weight in people with obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04350892 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the effectiveness of bariatric surgery in treating obesity by examining cerebrospinal fluid (CSF) biomarkers related to brain activity. Participants undergoing Roux-en-Y gastric bypass or sleeve gastrectomy will have their CSF and blood analyzed before and after surgery, as well as compared to individuals on a very low-calorie diet. The study will focus on neuropeptides, hormones, and proteins that regulate appetite and body weight, with the goal of uncovering unique biomarkers associated with surgical weight loss. By understanding the central nervous system's response to these surgical interventions, the research seeks to explain the long-term success of bariatric surgery in weight management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI between 35 and 55 who are planning to undergo bariatric surgery.
Not a fit: Patients with significant medical conditions, recent weight changes, or those on medications affecting weight or glucose levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into why bariatric surgery is more effective than diet-induced weight loss, potentially leading to improved treatment strategies for obesity.
How similar studies have performed: While studies on bariatric surgery exist, this specific focus on cerebrospinal fluid biomarkers and their relationship to brain mechanisms in obesity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Sharon L Wardlaw, MD — Columbia University
- Study coordinator: Sarah Borden, MS
- Email: sb1097@cumc.columbia.edu
- Phone: 212-305-4006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Weight Loss, Low Calorie Diet