A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

Obesity Clinical Trial

— FGB  

Official title:

A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03091725
• Other study ID #: 201612107
• Secondary ID: UL1TR000448KL2TR
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Beth Henk
• Phone: 314-362-8250
• Email: bhenk[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bariatric surgery markedly improves glycemic control in persons with Type 2 Diabetes (T2D). Roux-en-Y gastric bypass (RYGB), a procedure that bypasses the upper gastrointestinal (UGI) tract, results in greater rates of diabetes resolution compared to methods that leave the UGI tract intact. Studies suggest that mechanisms beyond weight-loss account for the superiority of RYGB compared to other surgical methods. These weight-loss independent metabolic effects may involve increased postprandial production and release of nutrition- responsive hormones. Fibroblast growth factor 21 (FGF21) is a nutrition-adaptive hormone with the potential to alleviate symptoms of diabetes and obesity. Preliminary data therefore suggest that RYGB surgery may alter postprandial FGF21 regulation which could be important for achieving post-meal nutrient homeostasis. Therefore, the goal of this study is to test how nutrient content of the meal affects FGF21 concentrations before and after weight loss induced by RYGB or very low calorie diet (VLCD) therapy. The importance of FGF21 for glucose, insulin, triglyceride, and adipose tissue and muscle metabolism in these two groups will also be tested.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

Surgery Group (RYGB):

• Males and Females

• Scheduled for RYGB surgery

• Body Mass Index 35-55 kg/m²

• Without Type 2 Diabetes (T2D)

VLCD group:

• Males and Females

• Body Mass Index 35-55 kg/m²

• Without Type 2 Diabetes (T2D)

Exclusion Criteria:

Surgery Group (RYGB):

• Regular use of tobacco products

• Previous intestinal resection

• Pregnant or breastfeeding

• Evidence of significant organ system dysfunction or disease other than obesity and T2D

• Use of any medication that might, in the opinion of the investigator, affect metabolic function

• Exercise =90 minutes per week

• Use or past use of hormone replacement therapy within the past 6 months

VLCD Group:

• Regular use of tobacco products

• Previous intestinal resection

• Pregnant or breastfeeding

• Evidence of significant organ system dysfunction or disease other than obesity and T2D

• Use of any medication that might, in the opinion of the investigator, affect metabolic function

• Exercise =90 minutes per week

• Use or past use of hormone replacement therapy within the past 6 months

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Roux-en-Y gastric bypass surgery
A bariatric surgery procedure which will help individuals achieve 16-18% weight loss

Behavioral:
• Very low-calorie diet
Subjects will meet with a dietitian and/or behaviorist over 4-6 months to lose 16-18% of their body weight.

Locations

Country	Name	City	State
United States	Beth Henk	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial FGF21 plasma concentrations	Concentrations of FGF21 protein will be measured in plasma after consuming a high glucose meal or a high fat meal, before and after surgery or low calorie diet.	9 months