FGB: A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

Sponsor

Washington University School of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03091725

Collaborator

National Center for Advancing Translational Science (NCATS) (NIH)

Enrollment

Location

Arms

70.2

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: Roux-en-Y gastric bypass surgery Behavioral: Very low-calorie diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB

Actual Study Start Date :

Apr 25, 2017

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RYGB group Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after 16-18% weight-loss	Procedure: Roux-en-Y gastric bypass surgery A bariatric surgery procedure which will help individuals achieve 16-18% weight loss
Active Comparator: VLCD Group Subjects in this group will participate in a very low-calorie diet intervention to obtain a 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.

Arm

Intervention/Treatment

Experimental: RYGB group

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

Procedure: Roux-en-Y gastric bypass surgery

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

Active Comparator: VLCD Group

Subjects in this group will participate in a very low-calorie diet intervention to obtain a 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.

Outcome Measures

Primary Outcome Measures

Postprandial FGF21 plasma concentrations [9 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine
National Center for Advancing Translational Science (NCATS)

Investigators

Principal Investigator: Lydia-Ann Harris, PhD, 314-362-8708
Principal Investigator: Samuel Klein, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT03091725

Other Study ID Numbers:

201612107
UL1TR000448
KL2TR000450

First Posted:

Mar 27, 2017

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Washington University School of Medicine

Obesity

Roux-en-Y gastric bypass (RYGB)

Very low calorie diet

Fibroblast growth factor 21 (FGF21)

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Apr 13, 2022