30 Participants Needed

Weight Loss Strategies for Obesity

(FGB Trial)

Recruiting at 1 trial location
BH
Overseen ByBeth Henk
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
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 compare the metabolic responses to low-carbohydrate and standard-carbohydrate meals in African Americans and non-Hispanic White adults with obesity and the effect of weight loss induced by low-calorie diet (LCD) or Roux-en-Y gastric bypass (RYGB) on the metabolic responses to low-carbohydrate and standard meals. Participants will consume: 1) a standard-carbohydrate meal (\~49 g glucose) and 2) a low-carbohydrate (\~3.4 g glucose) meal on separate study visits performed in a randomized order. We will evaluate the meals' effect before and after \~16-18% weight loss on postprandial i) insulin kinetics, ii) glucose kinetics iii) β-cell function; iv) plasma triglyceride and non-esterified fatty acid concentrations; v) plasma hormone concentrations; vi) plasma cytokine concentrations; vi) plasma metabolomics; and vii) adipose tissue transcriptomics.

Do I need to stop my current medications for this trial?

Yes, you may need to stop taking medications that could affect metabolic function, as determined by the investigator.

What safety data exists for Roux-en-Y gastric bypass and very low-calorie diets?

Roux-en-Y gastric bypass (RYGB) is widely reported as a safe and effective procedure for weight loss and improving metabolism, especially in patients with high BMI. It is considered the gold standard for bariatric surgery, leading to sustained weight loss and improvement in obesity-related conditions. Studies show RYGB is associated with lower rates of major adverse cardiovascular events and mortality in obese patients. However, there is a risk of long-term nutritional deficiencies, particularly in adolescents who do not adhere to supplementation. The safety of very low-calorie diets (VLCD) is not specifically addressed in the provided research.12345

Is Roux-en-Y gastric bypass surgery a promising treatment for weight loss in obesity?

Yes, Roux-en-Y gastric bypass surgery is a promising treatment for weight loss in obesity. It is highly effective in helping people lose weight and improve health issues related to obesity. It also changes food preferences, making people less interested in high-energy foods, and leads to greater weight loss compared to other procedures like gastric banding.678910

What data supports the idea that Weight Loss Strategies for Obesity is an effective treatment?

The available research shows that Roux-en-Y gastric bypass (RYGB) is a very effective treatment for obesity, leading to significant long-term weight loss and improvement in related health issues. However, some patients may experience weight regain over time. Studies indicate that RYGB is more effective than other surgical options like vertical banded gastroplasty (VBG) and bilio-pancreatic diversion (BPD), although it can lead to nutritional deficiencies if not managed properly. Overall, RYGB is considered one of the most effective treatments for obesity, despite the potential for weight regain in some patients.68111213

Who Is on the Research Team?

Samuel Klein, MD | Division of ...

Samuel Klein, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for men and women with obesity, having a BMI of 35-55 kg/m², who are scheduled for RYGB surgery or will follow a very low-calorie diet (VLCD), but do not have Type 2 Diabetes. Participants should not be pregnant, breastfeeding, using tobacco products regularly, exercising more than 90 minutes per week, or have had hormone replacement therapy in the last six months.

Inclusion Criteria

I have a BMI between 35-55 and do not have Type 2 Diabetes.
I am scheduled for RYGB surgery, my BMI is between 35-55, and I do not have Type 2 Diabetes.

Exclusion Criteria

VLCD Group: Exercise ≥90 minutes per week
I am not on medication that affects my metabolism.
I am not on medication that affects metabolism, as per my doctor's opinion.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a low-calorie diet intervention or Roux-en-Y gastric bypass surgery to achieve ~16-18% weight loss

4-6 months
Multiple visits for meal consumption and assessments

Post-Intervention Assessment

Metabolic responses to low-carbohydrate and standard-carbohydrate meals are evaluated, including insulin kinetics, glucose kinetics, and other metabolic parameters

1-2 weeks
2 visits (in-person) for meal consumption and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Roux-en-Y gastric bypass surgery
  • Very low-calorie diet
Trial Overview The study investigates how Roux-en-Y gastric bypass (RYGB) surgery versus a very low-calorie diet affects levels of FGF21—a hormone that may help regulate post-meal nutrient balance and improve symptoms of diabetes and obesity. It also examines the impact on glucose, insulin, triglyceride metabolism as well as fat and muscle tissue function.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: RYGB groupExperimental Treatment1 Intervention
Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after \~16-18% weight-loss
Group II: LCD GroupActive Control1 Intervention
Subjects in this group will participate in a low-calorie diet intervention to achieve \~16-18% weight loss.

Roux-en-Y gastric bypass surgery is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Roux-en-Y gastric bypass for:
  • Type 2 Diabetes
  • Obesity
🇪🇺
Approved in European Union as Roux-en-Y gastric bypass for:
  • Type 2 Diabetes
  • Obesity
🇨🇦
Approved in Canada as Roux-en-Y gastric bypass for:
  • Type 2 Diabetes
  • Obesity

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Kilo Diabetes & Vascular Research Foundation

Collaborator

Trials
1
Recruited
30+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials
100
Recruited
32,100+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Published Research Related to This Trial

In a study of 32 obese patients who underwent conversion from Roux-en-Y gastric bypass (RYGB) to duodenal switch (DS), the patients achieved a mean excess weight loss (EWL) of 56.4% by 24 months post-surgery, indicating the effectiveness of this revision procedure.
The study found no significant difference in weight loss outcomes between two types of DS procedures (RYDS and single anastomosis DS), suggesting that both methods are equally effective for patients seeking further weight loss after failed RYGB.
Mid-term outcomes of gastric bypass weight loss failure to duodenal switch.Surve, A., Zaveri, H., Cottam, D., et al.[2022]
In a study of 1426 obese patients who underwent Roux-en-Y gastric bypass (RYGB), 17.1% experienced significant weight regain (≥15% of their 1-year postoperative weight) after an average of 6 years post-surgery.
Younger age was identified as a significant predictor of weight regain, even when accounting for the time elapsed since surgery, highlighting the need for further research into the factors influencing weight loss and regain after RYGB.
Predictors of weight regain in patients who underwent Roux-en-Y gastric bypass surgery.Shantavasinkul, PC., Omotosho, P., Corsino, L., et al.[2022]
In a study analyzing serum samples from 21 patients who regained weight after Roux-en-Y gastric bypass (RYGB) and 14 patients who maintained weight loss, a distinct metabolomic fingerprint was found in those with weight regain, primarily involving amino acid and one-carbon metabolism.
The findings suggest that specific serum metabolites, particularly those related to serine, glycine, and threonine pathways, could potentially serve as biomarkers to predict which patients are at risk of weight regain after RYGB.
Differential Metabolomic Signatures in Patients with Weight Regain and Sustained Weight Loss After Gastric Bypass Surgery: A Pilot Study.Abidi, W., Nestoridi, E., Feldman, H., et al.[2021]

Citations

Mid-term outcomes of gastric bypass weight loss failure to duodenal switch. [2022]
Predictors of weight regain in patients who underwent Roux-en-Y gastric bypass surgery. [2022]
Differential Metabolomic Signatures in Patients with Weight Regain and Sustained Weight Loss After Gastric Bypass Surgery: A Pilot Study. [2021]
The Benefits of Banded over Non-banded Roux-en-Y Gastric Bypass in Patients with Morbid Obesity: a Multi-center Study. [2022]
Managing the obese patient after bariatric surgery: a case report of severe malnutrition and review of the literature. [2017]
Weight loss at six months is the surrogate of long-term treatment outcomes for obese Chinese with a BMI less than 35 kg/m2 undergoing Roux-en-Y gastric bypass. [2022]
Two-year outcomes of Roux-en-Y gastric bypass vs medical treatment in type 2 diabetes with a body mass index lower than 32.5 kg/m2: a multicenter propensity score-matched analysis. [2022]
The role of alimentary and biliopancreatic limb length in outcomes of Roux-en-Y gastric bypass. [2022]
The Long-Term Impact of Bariatric Surgery on Development of Atrial Fibrillation and Cardiovascular Events in Obese Patients: An Historical Cohort Study. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Micronutrient intake and biochemistry in adolescents adherent or nonadherent to supplements 5 years after Roux-en-Y gastric bypass surgery. [2020]
FROM COMPLEX EVOLVING TO SIMPLE: CURRENT REVISIONAL AND ENDOSCOPIC PROCEDURES FOLLOWING BARIATRIC SURGERY. [2022]
Altered neural responsivity to food cues in relation to food preferences, but not appetite-related hormone concentrations after RYGB-surgery. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Long-Term Modulation of Appetitive Hormones and Sweet Cravings After Adjustable Gastric Banding and Roux-en-Y Gastric Bypass. [2022]
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