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

March 27, 2017 updated by: Rijnstate Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Good responder RYGB
Good responders after Roux-en-Y gastric bypass (RYGB). EWL > 50%. Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Radiation: 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)
Other: Determination of gut hormones
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
Other: Bad responder RYGB
Bad responders after Roux-en-Y gastric bypass (RYGB). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Radiation: 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)
Other: Determination of gut hormones
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
Other: Good responder SG
Good responders after sleeve gastrectomy (SG). EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Radiation: 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)
Other: Determination of gut hormones
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
Other: Bad responder SG
Bad responders after sleeve gastrectomy (SG). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
Radiation: 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)
Other: Determination of gut hormones
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
Other: Duodenal-jejunal bypass liner
Patients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL
Radiation: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying rate after bariatric surgery
Time Frame: 2 years after surgery
In the RYGB and SG group
2 years after surgery
Change in gastric emptying rate after implantation of DJBL
Time Frame: before and 1 month after
In the DJBL group
before and 1 month after

Secondary Outcome Measures

Outcome Measure
Time Frame
Gut hormone levels after standard meal
Time Frame: 2 years after surgery
2 years after surgery
Weight loss after bariatric surgery
Time Frame: 2 years after bariatric surgery
2 years after bariatric surgery
Quality of life (SF-36, BAROS) after bariatric surgery
Time Frame: 2 years after bariatric surgery
2 years after bariatric surgery
Change in quality of life (SF-36, BAROS) after DJBL
Time Frame: Before and 1 month after implantation of DJBL
Before and 1 month after implantation of DJBL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: Frits J Berends, MD, PhD, Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL50111.091.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morbid Obesity

Clinical Trials on Gastric emptying scintigraphy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe