← Back to Search

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

No Placebo-Only Group

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.

Select...

I am not taking diabetes medications, beta-blockers, opiates, or glucocorticoids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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.