Morbid ObesityNCT03384303
Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass
A study testing Standardized meal test in people with Morbid Obesity, run by Rijnstate Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Standardized meal test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric
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.
- Conditions
- Morbid Obesity
- Being tested
- Standardized meal test
- Keywords
- Incretines, Bile acids, Gut hormones, Limb lengths, Biliopancreatic limb, Bariatric surgery, Gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized meal testOther
Preoperatively and postoperatively standardized meal test
| Study group | Role | What they receive |
|---|---|---|
| LBPL-RYGB | Other | Not described Receives: Other: Standardized meal test |
| S-RYGB | Other | Not described Receives: Other: Standardized meal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline incretine levels during a standardized meal test four weeks after surgery.
Measured: Preoperatively and four weeks after surgery
Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.
Measured: Preoperatively and four weeks after surgery
Change from baseline bile acid levels during a standardized meal test four weeks after surgery.
Measured: Preoperatively and four weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Oct 2015
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Principal investigator, Frits Berends, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384303
- Sponsor's protocol ID
- 2014-1359
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric
- ClinicalTrials.gov ID
- NCT03384303
- Acronym / sponsor ID
- 2014-1359
- Conditions
- Morbid Obesity
- Keywords
- Incretines, Bile acids, Gut hormones, Limb lengths, Biliopancreatic limb, Bariatric surgery, Gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBPL-RYGB | Other | Other: Standardized meal test |
| S-RYGB | Other | Other: Standardized meal test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized meal testPreoperatively and postoperatively standardized meal test | Other | LBPL-RYGB, S-RYGB |
Primary outcome
Change from baseline incretine levels during a standardized meal test four weeks after surgery.
Time frame: Preoperatively and four weeks after surgery
Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.
Time frame: Preoperatively and four weeks after surgery
Change from baseline bile acid levels during a standardized meal test four weeks after surgery.
Time frame: Preoperatively and four weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized meal test in people with Morbid Obesity, run by Rijnstate Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline incretine levels during a standardized meal test four weeks after surgery. (time frame: Preoperatively and four weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.