Bariatric Procedures and Changes in Incretins and Gastric Emptying

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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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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Detailed Description

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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

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Morbid Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Good responder RYGB

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

Group Type OTHER

Gastric emptying scintigraphy

Intervention Type 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

Intervention Type OTHER

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

Bad responder RYGB

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

Group Type OTHER

Gastric emptying scintigraphy

Intervention Type 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

Intervention Type OTHER

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

Good responder SG

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

Group Type OTHER

Gastric emptying scintigraphy

Intervention Type 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

Intervention Type OTHER

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

Bad responder SG

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

Group Type OTHER

Gastric emptying scintigraphy

Intervention Type 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

Intervention Type OTHER

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

Duodenal-jejunal bypass liner

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

Group Type OTHER

Gastric emptying scintigraphy

Intervention Type RADIATION

Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)

Interventions

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Gastric emptying scintigraphy

Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)

Intervention Type RADIATION

Determination of gut hormones

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No