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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

FGB Trial 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.Check my eligibility
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.See study design
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.

FGB Trial 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.

FGB Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postprandial FGF21 plasma concentrations

FGB 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
36,276 Total Patients Enrolled
1 Trials studying Obesity
42 Patients Enrolled for Obesity
Washington University School of MedicineLead Sponsor
1,942 Previous Clinical Trials
2,304,271 Total Patients Enrolled
78 Trials studying Obesity
13,902 Patients Enrolled for Obesity
National Center for Advancing Translational Sciences (NCATS)NIH
322 Previous Clinical Trials
401,521 Total Patients Enrolled
12 Trials studying Obesity
4,011 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be the best suited candidates for this experiment?

"Eligible individuals for this research must suffer from obesity, be aged 25 to 65 years old. A total of 24 participants will be taken into the study."

Answered by AI

Does this research project restrict itself to younger demographics?

"The age range that is eligible for this study starts at 25 and concludes when the patient reaches 65 years old."

Answered by AI

Are people still being accepted into the program?

"The clinical trial in question is no longer actively recruiting patients, as the last update to the posting on clinicaltrials.gov was made over 4 months ago. 998 other trials are still looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
Washington University School of Medicine
Beth Henk
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Washington University School of Medicine: < 48 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB
2017. "A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03091725.
All > Obesity
~3 spots leftby Jul 2025
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