Roux-en-Y Gastric Bypass Surgery for Obesity

Columbia University Medical Center, New York, NY
ObesityRoux-en-Y Gastric Bypass (RYGB) - Procedure
18 - 65
All Sexes
What conditions do you have?

Study Summary

This trial is investigating why bariatric surgery is more effective than diet-induced weight loss in reducing obesity, with a focus on brain mechanisms. CSF neuropeptide, hormone, and protein levels will be measured to determine if some of the changes that are expected to occur after diet-induced weight loss do not occur after bariatric surgery.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 12 months

Up to 12 months
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.
Comparison of changes in CSF cortisol (ng/mL) that occur in subjects after diet induced weight loss compared to RYGB and SG.
Comparison of changes in the CSF proteome that occur after diet-induced weight-loss compared to RYGB and SG using unbiased proteomic analysis.
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.

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Roux-en-Y Gastric Bypass Surgery
1 of 3
Sleeve Gastrectomy Surgery
1 of 3
Very Low Calorie Diet
1 of 3

Active Control

48 Total Participants · 3 Treatment Groups

Primary Treatment: Roux-en-Y Gastric Bypass Surgery · No Placebo Group · N/A

Roux-en-Y Gastric Bypass Surgery
ActiveComparator Group · 1 Intervention: Roux-en-Y Gastric Bypass (RYGB) · Intervention Types: Procedure
Sleeve Gastrectomy Surgery
ActiveComparator Group · 1 Intervention: Sleeve Gastrectomy (SG) · Intervention Types: Procedure
Very Low Calorie Diet
ActiveComparator Group · 1 Intervention: Very Low Calorie Diet (VLCD) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,336 Previous Clinical Trials
1,626,381 Total Patients Enrolled
36 Trials studying Obesity
4,874 Patients Enrolled for Obesity
Sharon L Wardlaw, MDPrincipal InvestigatorColumbia University

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 18 and 65 years of age.
Your body mass index (BMI) falls between 35 and 55.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Columbia University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I suffer from sleep apnea and knees,back, ankle arthritis along as well as ASTHMA SO I MUST start LOOSING 60 lbs.asap."
How many prior treatments have patients received?

How responsive is this trial?

Most responsive sites:
  1. Columbia University Medical Center: < 24 hours
Average response time
  • < 1 Day
Typically responds via

Frequently Asked Questions

Do I satisfy all the criteria necessary to partake in this research?

"This trial is seeking 48 individuals with obesity between the age of majority and seniority. The Body Mass Index (BMI) must be in-between 35 to 55, otherwise they will not meet the requirements for inclusion into this study." - Anonymous Online Contributor

Unverified Answer

Is the study currently recruiting participants?

" confirms that this medical study is still recruiting, with the initial posting occurring on October 20th 2020 and last update logged as March 21st 2022." - Anonymous Online Contributor

Unverified Answer

How many people are eligible to participate in this experiment?

"Yes, according to the research is actively enrolling participants. This experiment was initially announced on October 20th 2020 and has been recently updated March 21st 2022. There are 48 spaces available at one location for this trial." - Anonymous Online Contributor

Unverified Answer

Does this trial include individuals aged 80 and over?

"The age range for applicants to this trial is 18-65. Nevertheless, there are 202 trials available for those below the lower limit and 596 experiments open to people above the upper boundary." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.