Weight Loss Strategies for Obesity
(FGB Trial)
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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either a low-calorie diet intervention or Roux-en-Y gastric bypass surgery to achieve ~16-18% weight loss
Post-Intervention Assessment
Metabolic responses to low-carbohydrate and standard-carbohydrate meals are evaluated, including insulin kinetics, glucose kinetics, and other metabolic parameters
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Roux-en-Y gastric bypass surgery
- Very low-calorie diet
Roux-en-Y gastric bypass surgery is already approved in United States, European Union, Canada for the following indications:
- Type 2 Diabetes
- Obesity
- Type 2 Diabetes
- Obesity
- Type 2 Diabetes
- Obesity
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Kilo Diabetes & Vascular Research Foundation
Collaborator
National Center for Advancing Translational Science (NCATS)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator