Morbid ObesityBIGNCT02539641
Bariatric Procedures and Changes in Incretins and Gastric Emptying
A study testing Gastric emptying scintigraphy and Determination of gut hormones in people with Morbid Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and in patients before and after the placement of a duodenal-jejunal bypass liner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric emptying scintigraphy and Determination of gut hormones
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 had a follow-up period up till 2 years after bariatric surgery without any complications or
- Patients are eligible for DJBL implantation
Who cannot join
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Pregnancy or giving breast feeding
- Gluten allergy
- Inability to stop medication that affects the motility of the upper GI tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- Endocrine disease influencing gastric emptying (diabetes mellitus, hyper- or hypothyroidism). Type 2 diabetes mellitus is not an exclusion criterium for patients receiving the DJBL.
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and in patients before and after the placement of a duodenal-jejunal bypass liner.
Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are determined.
Read the detailed description
Bariatric surgery reduces stomach volume and passage of foods through the gastrointestinal tract is altered. The satiety level often increases, which is probably caused by gut hormones. Patients response on different bariatric procedures varies widely and it is difficult to predict which patient responds well. Possibly, patients who have successful excess weight loss (EWL) two years after surgery have different gastric emptying rates compared to unsuccessful patients.
Changes in gut hormones after implantation of a duodenal-jejunal bypass liner were demonstrated in other studies. However, gastric emptying before and after placement of this liner is unknown.
- Conditions
- Morbid Obesity
- Being tested
- Gastric emptying scintigraphy, Determination of gut hormones
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying scintigraphyRadiation
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
Determination of gut hormonesOther
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
| Study group | Role | What they receive |
|---|---|---|
| Good responder RYGB | Other | Good responders after Roux-en-Y gastric bypass (RYGB). EWL > 50%. Interventions: Gastric emptying scintigraphy and Determination of gut hormones. Receives: Radiation: Gastric emptying scintigraphy; Other: Determination of gut hormones |
| Bad responder RYGB | Other | Bad responders after Roux-en-Y gastric bypass (RYGB). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. Receives: Radiation: Gastric emptying scintigraphy; Other: Determination of gut hormones |
| Good responder SG | Other | Good responders after sleeve gastrectomy (SG). EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. Receives: Radiation: Gastric emptying scintigraphy; Other: Determination of gut hormones |
| Bad responder SG | Other | Bad responders after sleeve gastrectomy (SG). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. Receives: Radiation: Gastric emptying scintigraphy; Other: Determination of gut hormones |
| Duodenal-jejunal bypass liner | Other | Patients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL Receives: Radiation: Gastric emptying scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying rate after bariatric surgery
In the RYGB and SG group
Measured: 2 years after surgery
Change in gastric emptying rate after implantation of DJBL
In the DJBL group
Measured: before and 1 month after
Secondary outcomes (4)
Gut hormone levels after standard meal
Measured: 2 years after surgery
Weight loss after bariatric surgery
Measured: 2 years after bariatric surgery
Quality of life (SF-36, BAROS) after bariatric surgery
Measured: 2 years after bariatric surgery
Change in quality of life (SF-36, BAROS) after DJBL
Measured: Before and 1 month after implantation of DJBL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frits J Berends, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539641
- Sponsor's protocol ID
- NL50111.091.14
- Acronym
- BIG
- Status last verified
- Mar 2017
- First submitted
- 20 Aug 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gersin KS, Keller JE, Stefanidis D, Simms CS, Abraham DD, Deal SE, Kuwada TS, Heniford BT. Duodenal- jejunal bypass sleeve: a totally endoscopic device for the treatment of morbid obesity. Surg Innov. 2007 Dec;14(4):275-8. doi: 10.1177/1553350607312901.
PubMed 18178916de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Junior AB, Halpern A, Cecconello I. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg. 2011 Jul;21(7):941-7. doi: 10.1007/s11695-011-0387-0.
PubMed 21442376de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.
PubMed 23526068Wang G, Agenor K, Pizot J, Kotler DP, Harel Y, Van Der Schueren BJ, Quercia I, McGinty J, Laferrere B. Accelerated gastric emptying but no carbohydrate malabsorption 1 year after gastric bypass surgery (GBP). Obes Surg. 2012 Aug;22(8):1263-7. doi: 10.1007/s11695-012-0656-6.
PubMed 22527599Dirksen C, Damgaard M, Bojsen-Moller KN, Jorgensen NB, Kielgast U, Jacobsen SH, Naver LS, Worm D, Holst JJ, Madsbad S, Hansen DL, Madsen JL. Fast pouch emptying, delayed small intestinal transit, and exaggerated gut hormone responses after Roux-en-Y gastric bypass. Neurogastroenterol Motil. 2013 Apr;25(4):346-e255. doi: 10.1111/nmo.12087. Epub 2013 Jan 29.
PubMed 23360316Braghetto I, Davanzo C, Korn O, Csendes A, Valladares H, Herrera E, Gonzalez P, Papapietro K. Scintigraphic evaluation of gastric emptying in obese patients submitted to sleeve gastrectomy compared to normal subjects. Obes Surg. 2009 Nov;19(11):1515-21. doi: 10.1007/s11695-009-9954-z. Epub 2009 Aug 28.
PubMed 19714384Melissas J, Daskalakis M, Koukouraki S, Askoxylakis I, Metaxari M, Dimitriadis E, Stathaki M, Papadakis JA. Sleeve gastrectomy-a "food limiting" operation. Obes Surg. 2008 Oct;18(10):1251-6. doi: 10.1007/s11695-008-9634-4. Epub 2008 Jul 29.
PubMed 18663545Baumann T, Kuesters S, Grueneberger J, Marjanovic G, Zimmermann L, Schaefer AO, Hopt UT, Langer M, Karcz WK. Time-resolved MRI after ingestion of liquids reveals motility changes after laparoscopic sleeve gastrectomy--preliminary results. Obes Surg. 2011 Jan;21(1):95-101. doi: 10.1007/s11695-010-0317-6.
PubMed 21088924Escalona A, Yanez R, Pimentel F, Galvao M, Ramos AC, Turiel D, Boza C, Awruch D, Gersin K, Ibanez L. Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):126-31. doi: 10.1016/j.soard.2009.12.009. Epub 2010 Jan 20.
PubMed 20359665
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Procedures and Changes in Incretins and Gastric Emptying
- ClinicalTrials.gov ID
- NCT02539641
- Acronym / sponsor ID
- BIG / NL50111.091.14
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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.
The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and in patients before and after the placement of a duodenal-jejunal bypass liner.
Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are determined.
Detailed description
Bariatric surgery reduces stomach volume and passage of foods through the gastrointestinal tract is altered. The satiety level often increases, which is probably caused by gut hormones. Patients response on different bariatric procedures varies widely and it is difficult to predict which patient responds well. Possibly, patients who have successful excess weight loss (EWL) two years after surgery have different gastric emptying rates compared to unsuccessful patients.
Changes in gut hormones after implantation of a duodenal-jejunal bypass liner were demonstrated in other studies. However, gastric emptying before and after placement of this liner is unknown.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Good responder RYGB | Other | Radiation: Gastric emptying scintigraphy, Other: Determination of gut hormonesGood responders after Roux-en-Y gastric bypass (RYGB). EWL > 50%. Interventions: Gastric emptying scintigraphy and Determination of gut hormones. |
| Bad responder RYGB | Other | Radiation: Gastric emptying scintigraphy, Other: Determination of gut hormonesBad responders after Roux-en-Y gastric bypass (RYGB). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. |
| Good responder SG | Other | Radiation: Gastric emptying scintigraphy, Other: Determination of gut hormonesGood responders after sleeve gastrectomy (SG). EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. |
| Bad responder SG | Other | Radiation: Gastric emptying scintigraphy, Other: Determination of gut hormonesBad responders after sleeve gastrectomy (SG). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. |
| Duodenal-jejunal bypass liner | Other | Radiation: Gastric emptying scintigraphyPatients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 had a follow-up period up till 2 years after bariatric surgery without any complications or
- Patients are eligible for DJBL implantation
Key exclusion criteria (6 listed)
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Pregnancy or giving breast feeding
- Gluten allergy
- Inability to stop medication that affects the motility of the upper GI tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
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 |
|---|---|---|
| Gastric emptying scintigraphyScintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA) | Radiation | Bad responder RYGB, Bad responder SG, Duodenal-jejunal bypass liner, Good responder RYGB, Good responder SG |
| Determination of gut hormonesGut hormone levels will be determined after eating a standard meal in the RYGB and SG groups. | Other | Bad responder RYGB, Bad responder SG, Good responder RYGB, Good responder SG |
Primary outcome
Gastric emptying rate after bariatric surgery
Time frame: 2 years after surgery
In the RYGB and SG group
Change in gastric emptying rate after implantation of DJBL
Time frame: before and 1 month after
In the DJBL group
4 secondary outcomes
Gut hormone levels after standard meal
Time frame: 2 years after surgery
Weight loss after bariatric surgery
Time frame: 2 years after bariatric surgery
Quality of life (SF-36, BAROS) after bariatric surgery
Time frame: 2 years after bariatric surgery
Change in quality of life (SF-36, BAROS) after DJBL
Time frame: Before and 1 month after implantation of DJBL
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 28 Mar 2017.
- Background: PubMed 18178916Gersin KS, Keller JE, Stefanidis D, Simms CS, Abraham DD, Deal SE, Kuwada TS, Heniford BT. Duodenal- jejunal bypass sleeve: a totally endoscopic device for the treatment of morbid obesity. Surg Innov. 2007 Dec;14(4):275-8. doi: 10.1177/1553350607312901.
- Background: PubMed 21442376de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Junior AB, Halpern A, Cecconello I. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg. 2011 Jul;21(7):941-7. doi: 10.1007/s11695-011-0387-0.
- Background: PubMed 23526068de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.
- Background: PubMed 22527599Wang G, Agenor K, Pizot J, Kotler DP, Harel Y, Van Der Schueren BJ, Quercia I, McGinty J, Laferrere B. Accelerated gastric emptying but no carbohydrate malabsorption 1 year after gastric bypass surgery (GBP). Obes Surg. 2012 Aug;22(8):1263-7. doi: 10.1007/s11695-012-0656-6.
- Background: PubMed 23360316Dirksen C, Damgaard M, Bojsen-Moller KN, Jorgensen NB, Kielgast U, Jacobsen SH, Naver LS, Worm D, Holst JJ, Madsbad S, Hansen DL, Madsen JL. Fast pouch emptying, delayed small intestinal transit, and exaggerated gut hormone responses after Roux-en-Y gastric bypass. Neurogastroenterol Motil. 2013 Apr;25(4):346-e255. doi: 10.1111/nmo.12087. Epub 2013 Jan 29.
- Background: PubMed 19714384Braghetto I, Davanzo C, Korn O, Csendes A, Valladares H, Herrera E, Gonzalez P, Papapietro K. Scintigraphic evaluation of gastric emptying in obese patients submitted to sleeve gastrectomy compared to normal subjects. Obes Surg. 2009 Nov;19(11):1515-21. doi: 10.1007/s11695-009-9954-z. Epub 2009 Aug 28.
- Background: PubMed 18663545Melissas J, Daskalakis M, Koukouraki S, Askoxylakis I, Metaxari M, Dimitriadis E, Stathaki M, Papadakis JA. Sleeve gastrectomy-a "food limiting" operation. Obes Surg. 2008 Oct;18(10):1251-6. doi: 10.1007/s11695-008-9634-4. Epub 2008 Jul 29.
- Background: PubMed 21088924Baumann T, Kuesters S, Grueneberger J, Marjanovic G, Zimmermann L, Schaefer AO, Hopt UT, Langer M, Karcz WK. Time-resolved MRI after ingestion of liquids reveals motility changes after laparoscopic sleeve gastrectomy--preliminary results. Obes Surg. 2011 Jan;21(1):95-101. doi: 10.1007/s11695-010-0317-6.
- Background: PubMed 20359665Escalona A, Yanez R, Pimentel F, Galvao M, Ramos AC, Turiel D, Boza C, Awruch D, Gersin K, Ibanez L. Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):126-31. doi: 10.1016/j.soard.2009.12.009. Epub 2010 Jan 20.
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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.
Frits J Berends, MD, PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric emptying scintigraphy and Determination of gut hormones in people with Morbid Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
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 4 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Gastric emptying rate after bariatric surgery (time frame: 2 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539641, which also lists 9 linked publications.
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 28 Mar 2017.