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

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ClinicalTrials.gov Identifier: NCT03091725
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Washington University School of Medicine

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 25, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

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.




Primary Outcome Measures :
  1. Postprandial FGF21 plasma concentrations [ Time Frame: 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.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091725


Contacts
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Contact: Johanna Sonnenschein, BA 314-747-2627 j.sonnenschein@wustl.edu
Contact: Rick Stein, PhD 314-286-0077 rstein@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Johanna Sonnenschein, BA    314-747-2627    j.sonnenschein@wustl.edu   
Contact: Rick Stein, PhD    314-286-0077    rstein@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Lydia-Ann Harris, PhD 314-362-8708
Principal Investigator: Samuel Klein, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03091725     History of Changes
Other Study ID Numbers: 201612107
UL1TR000448 ( U.S. NIH Grant/Contract )
KL2TR000450 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Nutrients
Growth Substances
Physiological Effects of Drugs