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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
Be older than 18 years old
Must not have
No medications that may affect body weight or blood glucose
No diabetes medications, beta-blockers, opiates or glucocorticoids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

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.
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.
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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not taking any medications that can change my weight or blood sugar levels.
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I am not taking diabetes medications, beta-blockers, opiates, or glucocorticoids.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
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?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,843 Total Patients Enrolled
459 Trials studying Obesity
589,502 Patients Enrolled for Obesity
Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,302 Total Patients Enrolled
41 Trials studying Obesity
5,992 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
~3 spots leftby Jan 2025
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