A Role for FGF21 in Postprandial Nutrient Homeostasis After RYGB (FGB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03091725|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: Roux-en-Y gastric bypass surgery Behavioral: Very low-calorie diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|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 :||March 2020|
|Estimated Study Completion Date :||March 2020|
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.
- 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.
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
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Lydia-Ann Harris, PhD||314-362-8708|
|Principal Investigator:||Samuel Klein, MD||Washington University School of Medicine|