Back to results

A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB (FGB)

Primary Purpose

Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Roux-en-Y gastric bypass surgery

Very low-calorie diet

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Roux-en-Y gastric bypass (RYGB), Very low calorie diet, Fibroblast growth factor 21 (FGF21)

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Beth HenkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RYGB group

VLCD Group

Arm Description

Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after 16-18% weight-loss

Subjects in this group will participate in a very low-calorie diet intervention to obtain a 16-18% weight loss.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03091725

First Posted

March 13, 2017

Last Updated

July 24, 2023

Sponsor

Washington University School of Medicine

Collaborators

National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT03091725

Brief Title

A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

Acronym

FGB

Official Title

A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Roux-en-Y gastric bypass (RYGB), Very low calorie diet, Fibroblast growth factor 21 (FGF21)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RYGB group

Arm Type

Experimental

Arm Description

Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after 16-18% weight-loss

Arm Title

VLCD Group

Arm Type

Active Comparator

Arm Description

Subjects in this group will participate in a very low-calorie diet intervention to obtain a 16-18% weight loss.

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y gastric bypass surgery

Intervention Description

A bariatric surgery procedure which will help individuals achieve 16-18% weight loss

Intervention Type

Behavioral

Intervention Name(s)

Very low-calorie diet

Intervention Description

Subjects will meet with a dietitian and/or behaviorist over 4-6 months to lose 16-18% of their body weight.

Primary Outcome Measure Information:

Title

Postprandial FGF21 plasma concentrations

Description

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.

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Henk

Phone

314-362-8250

bhenk@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Klein, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Henk

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Henk

Phone

314-362-8250

bhenk@wustl.edu

12. IPD Sharing Statement

Learn more about this trial

A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

We'll reach out to this number within 24 hrs