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Weight Loss Strategies for Obesity (FGB Trial)

N/A
Recruiting
Led By Lydia-Ann Harris, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
VLCD group: Males and Females with Body Mass Index 35-55 kg/m² and without Type 2 Diabetes (T2D)
Surgery Group (RYGB): Males and Females scheduled for RYGB surgery with Body Mass Index 35-55 kg/m² and without Type 2 Diabetes (T2D)
Must not have
Surgery Group (RYGB): Evidence of significant organ system dysfunction or disease other than obesity and T2D
Surgery Group (RYGB): Regular use of tobacco products
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Summary

This trial will test how nutrients affect the hormone FGF21 before and after weight loss surgery or a very low calorie diet.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for this trial's interventions (RYGB surgery & VLCD), common risks associated with RYGB include nutritional deficiencies, digestive issues like nausea or vomiting; VLCD can lead to fatigue or gallstone formation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a BMI between 35-55 and do not have Type 2 Diabetes.
Select...
I am scheduled for RYGB surgery, my BMI is between 35-55, and I do not have Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no major organ problems besides obesity and type 2 diabetes.
Select...
I regularly use tobacco products.
Select...
I am not pregnant or breastfeeding.
Select...
I have had part of my intestine surgically removed.
Select...
I have health issues not related to my obesity or type 2 diabetes.
Select...
I have had part of my intestines removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postprandial FGF21 plasma concentrations

Trial Design

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: VLCD GroupActive Control1 Intervention
Subjects in this group will participate in a very low-calorie diet intervention to obtain a 16-18% weight loss.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roux-en-Y gastric bypass surgery
2010
N/A
~160

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
36,247 Total Patients Enrolled
1 Trials studying Obesity
42 Patients Enrolled for Obesity
Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,599 Total Patients Enrolled
81 Trials studying Obesity
14,129 Patients Enrolled for Obesity
National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
410,444 Total Patients Enrolled
14 Trials studying Obesity
4,434 Patients Enrolled for Obesity
~2 spots leftby Jul 2025
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