Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized meal test
Sponsored by
About this trial
This is an interventional basic science trial for Morbid Obesity focused on measuring Incretines, Bile acids, Gut hormones, Limb lengths, Biliopancreatic limb, Bariatric surgery, Gastric bypass
Eligibility Criteria
Inclusion Criteria:
- General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007).
- Age > 18 years
- Patients must be able to adhere to the study visit schedule and protocol requirements
- Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
- Patients who are planned for a LRYGB
Exclusion Criteria:
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Pregnancy and when giving breast feeding
- A medical history of bariatric surgery
- Patients with a language barrier which can inhibit patients to follow the correct medical advice
- Any kind of genetic disorder that can inhibit patients to follow the correct medical advice
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LBPL-RYGB
S-RYGB
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline incretine levels during a standardized meal test four weeks after surgery.
Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.
Change from baseline bile acid levels during a standardized meal test four weeks after surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT03384303
First Posted
December 4, 2017
Last Updated
December 19, 2017
Sponsor
Rijnstate Hospital
Collaborators
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT03384303
Brief Title
Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass
Official Title
Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
May 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rijnstate Hospital
Collaborators
University College Dublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity is an increasing world wide problem. Moreover, the increase in patients who are considered morbidly obese is even higher (Sturm et al, Healt Aff 2004). Conservative approaches such as diets or medication are unsuccessful in the majority of the patients. Additionally, (morbid) obesity leads often to cardiovascular diseases, such as hypertension, dyslipidemia and type 2 diabetes (T2DM). When patients need insulin to regulate their glucose levels, their weight is even more difficult to control. Therefore, bariatric procedures are increasingly performed, with over 8.000 procedures in the Netherlands in 2013. The two most performed types of bariatric surgery in the Netherlands are the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and the Laparoscopic Sleeve Gastrectomy (LSG). Within the LRYGB there are different variants available. In a recently initiated randomized controlled trial (RCT) from our centre, a comparison between two variants of RYGB was performed. In this RCT our standard RYGB (s-RYGB:alimentary limb (AL) of 150cm; biliopancreatic limb (BPL) of 75cm) was compared with a RYGB with an long BPL (LBPLRYGB:AL of 75cm and a BPL of 150cm). A LBPLRYGB might improve weight loss and reduction after surgery. The exact mechanism of action is still not fully understood. Stomach volume is decreased and satiety levels often increase, probably due to changes in incretin levels. Passage of foods through the gastrointestinal tract are altered after RYGB. A possible explanation might be found in different levels of incretins (such as GLP-1, PYY and ghrelin) and bile acids (FGF-19 and FGF-21) after bariatric surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Incretines, Bile acids, Gut hormones, Limb lengths, Biliopancreatic limb, Bariatric surgery, Gastric bypass
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBPL-RYGB
Arm Type
Other
Arm Title
S-RYGB
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Standardized meal test
Intervention Description
Preoperatively and postoperatively standardized meal test
Primary Outcome Measure Information:
Title
Change from baseline incretine levels during a standardized meal test four weeks after surgery.
Time Frame
Preoperatively and four weeks after surgery
Title
Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.
Time Frame
Preoperatively and four weeks after surgery
Title
Change from baseline bile acid levels during a standardized meal test four weeks after surgery.
Time Frame
Preoperatively and four weeks after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007).
Age > 18 years
Patients must be able to adhere to the study visit schedule and protocol requirements
Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
Patients who are planned for a LRYGB
Exclusion Criteria:
Binge-eating or associated eating disorder
Active drug or alcohol addiction
Pregnancy and when giving breast feeding
A medical history of bariatric surgery
Patients with a language barrier which can inhibit patients to follow the correct medical advice
Any kind of genetic disorder that can inhibit patients to follow the correct medical advice
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass
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