NCT02539641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

August 20, 2015

Last Update Submit

March 27, 2017

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (2)

  • Gastric emptying rate after bariatric surgery

    In the RYGB and SG group

    2 years after surgery

  • Change in gastric emptying rate after implantation of DJBL

    In the DJBL group

    before and 1 month after

Secondary Outcomes (4)

  • Gut hormone levels after standard meal

    2 years after surgery

  • Weight loss after bariatric surgery

    2 years after bariatric surgery

  • Quality of life (SF-36, BAROS) after bariatric surgery

    2 years after bariatric surgery

  • Change in quality of life (SF-36, BAROS) after DJBL

    Before and 1 month after implantation of DJBL

Study Arms (5)

Good responder RYGB

OTHER

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

Radiation: Gastric emptying scintigraphyOther: 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.

Radiation: Gastric emptying scintigraphyOther: 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.

Radiation: Gastric emptying scintigraphyOther: 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.

Radiation: Gastric emptying scintigraphyOther: 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

Radiation: Gastric emptying scintigraphy

Interventions

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)

Bad responder RYGBBad responder SGDuodenal-jejunal bypass linerGood responder RYGBGood responder SG
Determination of gut hormonesOTHER

Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.

Bad responder RYGBBad responder SGGood responder RYGBGood responder SG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate hospital

Arnhem, Netherlands

Location

Related Publications (9)

  • 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.

    PMID: 18178916BACKGROUND

  • 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.

    PMID: 21442376BACKGROUND

  • 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.

    PMID: 23526068BACKGROUND

  • 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.

    PMID: 22527599BACKGROUND

  • 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.

    PMID: 23360316BACKGROUND

  • 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.

    PMID: 19714384BACKGROUND

  • 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.

    PMID: 18663545BACKGROUND

  • 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.

    PMID: 21088924BACKGROUND

  • 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.

    PMID: 20359665BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frits J Berends, MD, PhD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2015

First Posted

September 3, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

May 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

NL(1)