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OpenTrials
Completed

NCT Number: NCT02539641

Bariatric Procedures and Changes in Incretins and Gastric Emptying

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate hospital

Arnhem, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gastric emptying scintigraphy

Radiation

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 hormones

Other

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

Primary outcomes

  1. Gastric emptying rate after bariatric surgery

    Time frame: 2 years after surgery

    In the RYGB and SG group

  2. Change in gastric emptying rate after implantation of DJBL

    Time frame: before and 1 month after

    In the DJBL group

Secondary outcomes

  1. Gut hormone levels after standard meal

    Time frame: 2 years after surgery

  2. Weight loss after bariatric surgery

    Time frame: 2 years after bariatric surgery

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

    Time frame: 2 years after bariatric surgery

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

    Time frame: Before and 1 month after implantation of DJBL

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Acronym: BIG

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 3, 2015
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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