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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether weight loss through surgery affects hormones controlling appetite and blood sugar differently than weight loss through diet. Participants will undergo either Roux-en-Y gastric bypass (a type of weight-loss surgery), sleeve gastrectomy (another form of weight-loss surgery), or follow a very low-calorie diet. Additionally, groups of obese and lean individuals will not receive any treatment, serving as control groups. This trial may suit those who are obese and not managing diabetes, special diets, or recent weight changes. As an unphased trial, it offers a unique opportunity to contribute to understanding weight-loss methods and their effects on hormones.

Will I have to stop taking my current medications?

If you are taking medications that affect body weight, you will need to stop them at least 3 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the weight loss treatments under study are generally well-tolerated.

For Roux-en-Y gastric bypass, studies have found it effective and safe for weight loss. A review of research indicates that both the long and short versions of this surgery carry a low risk of complications.

Sleeve gastrectomy also appears quite safe. One study found it has a lower risk of death and complications compared to other methods. The overall risk of major complications with bariatric surgery, including sleeve gastrectomy, is about 4%.

The very low calorie diet is generally safe when supervised by a dietitian. Studies have shown it leads to significant weight loss with an acceptable safety profile.

Overall, these treatments are considered safe for weight loss, but like any medical procedure or diet, they carry some risks. It is important to consult healthcare providers to determine what might be best for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring different weight-loss methods for obesity because they offer varied approaches to tackling a complex condition. Sleeve gastrectomy and Roux-en-Y gastric bypass are surgical methods that physically alter the digestive system to limit food intake and absorption, often leading to significant weight loss and improvements in metabolic health. Meanwhile, the very low-calorie diet offers a non-surgical alternative, significantly reducing calorie intake to promote weight loss. This trial investigates how these methods compare, specifically for diabetic and non-diabetic patients, to understand their effectiveness and impact on health beyond weight reduction.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that Roux-en-Y gastric bypass surgery, one of the treatments in this trial, leads to significant and lasting weight loss. Studies found that 72% of patients maintained at least a 20% weight loss even after 10 years. Sleeve gastrectomy, another treatment option in this trial, also proves effective, with patients losing about 22.5% of their body weight after five years. Both surgeries outperform non-surgical methods. For the very low-calorie diet, also under study in this trial, research indicates it results in more short-term weight loss compared to less strict diets, with losses ranging from 8 to 21 kg in different studies. Each method has proven effective in aiding weight loss. ^{2 6 7 8 9}

Who Is on the Research Team?

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

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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40709782/

Evaluating the Effectiveness and Long-term Outcomes of ... Results: RYGB was associated with more significant long-term weight loss and superior T2DM remission rates. SG had a lower risk of nutritional ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1700459

Weight and Metabolic Outcomes 12 Years after Gastric ... Furthermore, at 10 years, 72% of the patients who had undergone Roux-en-Y gastric bypass had maintained at least a 20% weight loss from baseline ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34953743/

10-year weight loss outcomes after Roux-en-Y gastric ... RYGB results in clinically significant and durable weight loss. Attendance at periodic follow-up visits does not appear to be associated with long-term ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606024001818

Comprehensive outcomes after Roux-en-Y gastric bypass ... The maximum mean percentage total weight loss achieved at 1 year was 31.5% ± 5.7% and was consistently >20% throughout follow-up. Sustained resolution of ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819400

Ten-Year Outcomes Following Roux-en-Y Gastric Bypass ... Total weight loss was 20.0% (95% CI, 15.3%-24.7%) for RYGB and 33.9% (95% CI, 27.8%-40.0%) for DS (P = .001). Mean serum lipid levels, except ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37140720/

a Systematic Review of Bariatric and Metabolic Surgery The rationale of this systematic review is to compare the safety and efficacy between Roux-en-Y gastric bypass (RYGB), one anastomosis gastric ...

7. jamanetwork.com jamanetwork.com/journals/jamasurgery/article-abstract/2830466

Long-Term Outcomes of Laparoscopic Roux-en-Y Gastric ... The SM-BOSS randomized clinical trial found no significant difference in weight loss between SG and RYGB in the intention-to-treat analysis.

8. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00025-7/fulltext

Roux-en-Y gastric bypass, adjustable gastric banding, or ... Metabolic and bariatric surgery can lead to 20–30% total weight loss. Trials show that obesity management medications can lead to reductions of ...

9. nature.com nature.com/articles/s41598-024-82200-5

Outcomes and complications after long versus short ... Both long and short-pouch gastric bypass surgeries are effective and safe for weight loss and remission of obesity-associated medical problems in patients with ...