Overseen ByJudith Korner, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Columbia University
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine if diet-induced weight loss causes different changes in hormones that control appetite and glucose control than surgery-induced weight loss. The overall research plan is a non-randomized prospective study of 3 different weight loss (WL) interventions and a lean and an obese healthy control group.
Eligibility Criteria
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.Inclusion Criteria
I am between 18 and 65 years old.
Exclusion Criteria
I have had weight loss surgery in the past.
Tobacco or opioid use
Altered Sleep-wake Cycle
+10 more
Participant Groups
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.
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
Roux-en-Y Gastric Bypass is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Metabolic Syndrome
🇺🇸 Approved in United States as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Gastroesophageal Reflux Disease (GERD)
🇨🇦 Approved in Canada as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Hypertension
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator