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Bariatric Surgery for Obesity

N/A
Recruiting
Led By Sharon L Wardlaw, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adults aged 18-65 with obesity, having a BMI between 35 and 55. Participants should not be on diabetes medications, beta-blockers, opiates or glucocorticoids; should have stable weight in the past six months; and must not use tobacco or abuse substances. Pregnant or breastfeeding individuals can't join the diet group.Check my eligibility
What is being tested?
The study compares brain changes in obese patients undergoing Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) to those following a Very Low Calorie Diet (VLCD). It measures cerebrospinal fluid to track appetite-regulating hormones before and after these interventions.See study design
What are the potential side effects?
Potential side effects from bariatric surgery like RYGB and SG include nutritional deficiencies, digestive issues, and surgical complications. VLCD may cause fatigue, gallstones, constipation or diarrhea due to drastic calorie reduction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 the CSF proteome that occur after diet-induced weight-loss compared to RYGB and SG using unbiased proteomic analysis.
Secondary outcome measures
Comparison of changes in CSF cortisol (ng/mL) that occur in subjects after diet induced weight loss compared to RYGB and SG.
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 Design

3Treatment groups
Active Control
Group I: Roux-en-Y Gastric Bypass SurgeryActive Control1 Intervention
Group II: Sleeve Gastrectomy SurgeryActive Control1 Intervention
Group III: Very Low Calorie DietActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,760 Total Patients Enrolled
40 Trials studying Obesity
5,951 Patients Enrolled for Obesity
Sharon L Wardlaw, MDPrincipal InvestigatorColumbia University

Media Library

Roux-en-Y Gastric Bypass (RYGB) Clinical Trial Eligibility Overview. Trial Name: NCT04350892 — N/A
Obesity Research Study Groups: Roux-en-Y Gastric Bypass Surgery, Sleeve Gastrectomy Surgery, Very Low Calorie Diet
Obesity Clinical Trial 2023: Roux-en-Y Gastric Bypass (RYGB) Highlights & Side Effects. Trial Name: NCT04350892 — N/A
Roux-en-Y Gastric Bypass (RYGB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04350892 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT04350892 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Is the study currently recruiting participants?

"Clinicaltrials.gov 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."

Answered by AI

How many people are eligible to participate in this experiment?

"Yes, according to clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

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.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Columbia University Medical Center: < 24 hours
Typically responds via
Email
~9 spots leftby Jan 2025