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

Rijnstate Hospital

Status: Completed

Conditions: Morbid Obesity

Treatments: Other: Determination of gut hormones; Radiation: Gastric emptying scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT02539641

NL50111.091.14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 5 patient groups

Good responder RYGB

Other group

Description:

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

Treatment:

Other: Determination of gut hormones

Radiation: Gastric emptying scintigraphy

Bad responder RYGB

Other group

Description:

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

Treatment:

Other: Determination of gut hormones

Radiation: Gastric emptying scintigraphy

Good responder SG

Other group

Description:

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

Treatment:

Other: Determination of gut hormones

Radiation: Gastric emptying scintigraphy

Bad responder SG

Other group

Description:

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

Treatment:

Other: Determination of gut hormones

Radiation: Gastric emptying scintigraphy

Duodenal-jejunal bypass liner

Other group

Description:

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

Treatment:

Radiation: Gastric emptying scintigraphy