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Bariatric Procedures and Changes in Incretins and Gastric Emptying (BIG)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Gastric emptying scintigraphy
Determination of gut hormones
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Morbid Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Rijnstate hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Good responder RYGB

Bad responder RYGB

Good responder SG

Bad responder SG

Duodenal-jejunal bypass liner

Arm Description

Good responders after Roux-en-Y gastric bypass (RYGB). EWL > 50%. Interventions: Gastric emptying scintigraphy and Determination of gut hormones.

Bad responders after Roux-en-Y gastric bypass (RYGB). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.

Good responders after sleeve gastrectomy (SG). EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.

Bad responders after sleeve gastrectomy (SG). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.

Patients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL

Outcomes

Primary Outcome Measures

Gastric emptying rate after bariatric surgery
In the RYGB and SG group
Change in gastric emptying rate after implantation of DJBL
In the DJBL group

Secondary Outcome Measures

Gut hormone levels after standard meal
Weight loss after bariatric surgery
Quality of life (SF-36, BAROS) after bariatric surgery
Change in quality of life (SF-36, BAROS) after DJBL

Full Information

First Posted
August 20, 2015
Last Updated
March 27, 2017
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02539641
Brief Title
Bariatric Procedures and Changes in Incretins and Gastric Emptying
Acronym
BIG
Official Title
Bariatric Procedures and Changes in Incretins and Gastric Emptying
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Good responder RYGB
Arm Type
Other
Arm Description
Good responders after Roux-en-Y gastric bypass (RYGB). EWL > 50%. Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Arm Title
Bad responder RYGB
Arm Type
Other
Arm Description
Bad responders after Roux-en-Y gastric bypass (RYGB). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Arm Title
Good responder SG
Arm Type
Other
Arm Description
Good responders after sleeve gastrectomy (SG). EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Arm Title
Bad responder SG
Arm Type
Other
Arm Description
Bad responders after sleeve gastrectomy (SG). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Arm Title
Duodenal-jejunal bypass liner
Arm Type
Other
Arm Description
Patients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL
Intervention Type
Radiation
Intervention Name(s)
Gastric emptying scintigraphy
Intervention Description
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
Intervention Type
Other
Intervention Name(s)
Determination of gut hormones
Intervention Description
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
Primary Outcome Measure Information:
Title
Gastric emptying rate after bariatric surgery
Description
In the RYGB and SG group
Time Frame
2 years after surgery
Title
Change in gastric emptying rate after implantation of DJBL
Description
In the DJBL group
Time Frame
before and 1 month after
Secondary Outcome Measure Information:
Title
Gut hormone levels after standard meal
Time Frame
2 years after surgery
Title
Weight loss after bariatric surgery
Time Frame
2 years after bariatric surgery
Title
Quality of life (SF-36, BAROS) after bariatric surgery
Time Frame
2 years after bariatric surgery
Title
Change in quality of life (SF-36, BAROS) after DJBL
Time Frame
Before and 1 month after implantation of DJBL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frits J Berends, MD, PhD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18178916
Citation
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.
Results Reference
background
PubMed Identifier
21442376
Citation
de 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.
Results Reference
background
PubMed Identifier
23526068
Citation
de 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.
Results Reference
background
PubMed Identifier
22527599
Citation
Wang 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. Erratum In: Obes Surg. 2013 Jul;23(7):1016.
Results Reference
background
PubMed Identifier
23360316
Citation
Dirksen 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.
Results Reference
background
PubMed Identifier
19714384
Citation
Braghetto 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.
Results Reference
background
PubMed Identifier
18663545
Citation
Melissas 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.
Results Reference
background
PubMed Identifier
21088924
Citation
Baumann 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.
Results Reference
background
PubMed Identifier
20359665
Citation
Escalona 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.
Results Reference
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Bariatric Procedures and Changes in Incretins and Gastric Emptying

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