70 Participants Needed

Weight-Loss Methods for Obesity

JK
GF
SB
Overseen BySarah Borden
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

JK

Judith Korner, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have had weight loss surgery in the past.
Tobacco or opioid use
Altered Sleep-wake Cycle
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo weight loss interventions including sleeve gastrectomy, Roux-en-Y gastric bypass, or very low calorie diet

Varies by intervention

Follow-up

Participants are monitored for changes in hormones and glycemic control after weight loss interventions

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Roux-en-Y Gastric Bypass
  • Sleeve Gastrectomy
  • Very Low Calorie Diet
Trial Overview 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.
How Is the Trial Designed?
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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+
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