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Procedure

Weight-Loss Methods for Obesity

N/A
Waitlist Available
Led By Judith Korner, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year
Awards & highlights

Summary

This trial will compare how different weight-loss methods affect hormones that control appetite and blood sugar.

Who is the study for?
This trial is for men and women aged 18-65 struggling with obesity and insulin resistance, who haven't had significant weight changes or bariatric surgery before, don't use tobacco or opioids, aren't pregnant, and don't have untreated thyroid disease, diabetes, special diet restrictions, certain medical conditions like heart failure or Crohn's disease.
What is being tested?
The study compares the effects of two types of bariatric surgery—Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGBP)—with a Very Low Calorie Diet (VLCD) on hormones that regulate appetite and glucose control. It includes healthy obese controls to measure outcomes against.
What are the potential side effects?
Potential side effects may include nutritional deficiencies due to reduced food intake post-surgery or on VLCD. Surgical risks can involve infection, bleeding, anesthesia complications. Long-term issues might include gallstones or gastrointestinal problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Sleeve Gastrectomy Diabetic and Non-diabeticExperimental Treatment1 Intervention
sleeve gastrectomy surgery
Group II: Gastric Bypass Diabetic and Non-diabeticExperimental Treatment1 Intervention
Roux-en-Y gastric bypass surgery
Group III: Obese Control GroupActive Control1 Intervention
Non-diabetic obese subjects
Group IV: Very Low Calorie Diet Diabetic and Non-diabeticActive Control1 Intervention
very low calorie diet
Group V: Lean Control GroupActive Control1 Intervention
Non-diabetic lean subjects

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
4,324,821 Total Patients Enrolled
459 Trials studying Obesity
589,480 Patients Enrolled for Obesity
Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,280 Total Patients Enrolled
41 Trials studying Obesity
5,970 Patients Enrolled for Obesity
Judith Korner, MD, PhDPrincipal Investigator - Columbia University
Morgan Stanley Children's Hospital, New York Presbyterian Hospital-Columbia Presbyterian Center, New York State Psychiatric Institute
Columbia University College Of Physicians And Surgeons (Medical School)
Ny And Presby Hospital (Residency)
~2 spots leftby Jan 2025
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