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CompletedNCT03384303Updated Dec 27, 2017

Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass

An interventional study of Standardized meal test in Morbid Obesity, sponsored by Rijnstate Hospital. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-27.

Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Morbid Obesity

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Keywords

  • Incretines
  • Bile acids
  • Gut hormones
  • Limb lengths
  • Biliopancreatic limb
  • Bariatric surgery
  • Gastric bypass
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Other
    LBPL-RYGB

    Other: Standardized meal test

  • Other
    S-RYGB

    Other: Standardized meal test

Interventions

  • OtherStandardized meal test

    Preoperatively and postoperatively standardized meal test

05

What researchers measure

Primary outcomes

  1. Change from baseline incretine levels during a standardized meal test four weeks after surgery.

    Time frame: Preoperatively and four weeks after surgery

  2. Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.

    Time frame: Preoperatively and four weeks after surgery

  3. Change from baseline bile acid levels during a standardized meal test four weeks after surgery.

    Time frame: Preoperatively and four weeks after surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03384303
Lead sponsor
Rijnstate Hospital
Collaborators
University College Dublin
Responsible party
Frits Berends (Head of research department bariatric surgery, Rijnstate Hospital) — Principal investigator
First posted
Dec 27, 2017
Start date
Oct 1, 2015
Primary completion
May 1, 2016
Completion
May 1, 2016
Last update
Dec 27, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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