Cerebrospinal Fluid Biomarkers in Bariatric Surgery

NCT04350892 | Completed DMC

• 2 other identifiers: AAAS84301R01DK124465
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Obesity; Bariatric Surgery; Gastric Bypass; Sleeve Gastrectomy; Weight Loss; Low Calorie Diet

Outcome Measures

Primary Outcomes (2)

• Change in the levels of cerebrospinal fluid (CSF) proopiomelanocortin (POMC) derived peptides (fmol/ml) that occur in subjects after diet induced weight loss compared to RYGB and SG.

  POMC plays a critical role in regulating energy balance and levels decrease in the hypothalamus after diet-induced weight loss; this may lead to weight regain after dieting.

  Up to 12 months

• Comparison of changes in the CSF proteome that occur after diet-induced weight-loss compared to RYGB and SG using unbiased proteomic analysis.

  Up to 12 months

Secondary Outcomes (2)

• Comparison of the changes in Agouti-related protein (AgRP) concentrations (fmol/ml) in CSF and plasma that occur in subjects after diet induced weight loss compared to RYGB and SG.

  Up to 12 months

• Comparison of changes in CSF cortisol (ng/mL) that occur in subjects after diet induced weight loss compared to RYGB and SG.

  Up to 12 months

Study Arms (3)

Roux-en-Y Gastric Bypass Surgery

ACTIVE COMPARATOR

Procedure: Roux-en-Y Gastric Bypass (RYGB)

Sleeve Gastrectomy Surgery

ACTIVE COMPARATOR

Procedure: Sleeve Gastrectomy (SG)

Very Low Calorie Diet

ACTIVE COMPARATOR

Behavioral: Very Low Calorie Diet (VLCD)

Interventions

Roux-en-Y Gastric Bypass (RYGB) PROCEDURE

This surgery is often called gastric bypass. It is a weight-loss surgery that involves creating a small stomach pouch and bypassing part of the small intestine. If you decide with your doctor to have gastric bypass, you can be enrolled on this arm of the study. A surgery date should be pending before the investigators screen you for the study. The study does not cover the cost of the Roux-en-Y gastric bypass.

Roux-en-Y Gastric Bypass Surgery

Sleeve Gastrectomy (SG) PROCEDURE

Sleeve gastrectomy, is a weight-loss surgery that involves removing about 80% of the stomach. If you decide with your doctor to have sleeve gastrectomy, you can be enrolled on this arm of the study. A surgery date should be pending before the investigators screen you for the study. The study does not cover the cost of the sleeve gastrectomy.

Sleeve Gastrectomy Surgery

Very Low Calorie Diet (VLCD) BEHAVIORAL

Weight loss with calorie restricted liquid diet. Participants will be placed on a 800 kcal/day diet for meal replacement (Optifast) provided by the investigator for 12 weeks. Participants will be monitored weekly by the study dietician and medical staff.

Very Low Calorie Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• BMI 35-55

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Sharon L Wardlaw, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Robert C. and Veronica Atkins Professor of Obesity Research

Model Details: Cohort

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: October 20, 2020
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)