Weight-Loss Methods for Obesity

Overseen By Sarah Borden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Weight loss drugs

Disqualifiers: Diabetes, Bariatric surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by intervention

70 Participants Needed

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.

Research Team

Judith Korner, MD, PhD

Principal Investigator

Columbia University

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.

Exclusion Criteria

I have had weight loss surgery in the past.

Tobacco or opioid use

Altered Sleep-wake Cycle

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Sleeve Gastrectomy Diabetic and Non-diabetic Experimental Treatment 1 Intervention

sleeve gastrectomy surgery

Group II: Gastric Bypass Diabetic and Non-diabetic Experimental Treatment 1 Intervention

Roux-en-Y gastric bypass surgery

Group III: Obese Control Group Active Control 1 Intervention

Non-diabetic obese subjects

Group IV: Very Low Calorie Diet Diabetic and Non-diabetic Active Control 1 Intervention

very low calorie diet

Group V: Lean Control Group Active Control 1 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

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+