ObesityGASTONNCT03783052
Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery
A study testing SmartPill in fasted state, SmartPill in fed state and Aspiration in people with Obesity and Bariatric Surgery Candidate, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Over the years, obesity has become a major public health concern. The increasing rates of obesity are associated with an enhanced demand for weight-loss with bariatric surgery as a treatment option. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- SmartPill in fasted state, SmartPill in fed state and Aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2018to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
Who cannot join
- History of gastric ulcers
- Disorders of swallowing
- Suspected strictures, fistulas or physiological GI obstruction.
- GI surgery within past three months
- Severe dysphagia to food or pills
- Crohns disease or diverticulitis
Show all 11Show fewer
- Use of implanted or portable electro-mechanical medical devices
- Known intolerance to the SmartPill device
- Known food allergies to any component of the meal
- History of multiple bariatric surgeries
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Over the years, obesity has become a major public health concern. The increasing rates of obesity are associated with an enhanced demand for weight-loss with bariatric surgery as a treatment option. Bariatric surgery procedures alter the anatomical structure of the gastrointestinal tract, which contributes to the postoperative weight loss. However, it is not sure how obesity and the anatomical alterations of bariatric surgery affect the gastrointestinal physiology including gastrointestinal pH, gastric emptying, intestinal transit time and concentration of enzymes.
Read the detailed description
During the visit in the obesity clinic, eligible patients will be approached for participation by the sub-investigator. Interested patients will receive information regarding the study and receive the information sheet containing the informed consent form. After signing the informed consent form, volunteers will be invited to come to the clinical research center:
- Healthy volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
- Obese volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
- Obese volunteers: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the stomach, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
- Volunteers after Sleeve Gastrectomy: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the sleeve, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
- Volunteers after Roux-en-Y gastric Bypass: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the pouch, the Roux limb and the common limb via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- SmartPill in fasted state, SmartPill in fed state, Aspiration, Gastric emptying scintigraphy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartPill in fasted stateDevice
SmartPill administration in fasted state
SmartPill in fed stateDevice
SmartPill administration in fed state
AspirationOther
Aspiration of gastrointestinal samples in fasted and fed state
Gastric emptying scintigraphyOther
Gastric emptying scintigraphy in fed state
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | 11 Healthy volunteers Receives: Device: SmartPill in fasted state; Device: SmartPill in fed state |
| Obese volunteers | Other | 11 Obese Volunteers Receives: Device: SmartPill in fasted state; Device: SmartPill in fed state |
| Roux-en-Y Gastric Bypass patients | Other | 6 volunteers with a Roux-en-Y Gastric Bypass Receives: Device: SmartPill in fasted state; Other: Aspiration; Other: Gastric emptying scintigraphy |
| Sleeve Gastrectomy patients | Other | 6 volunteers with a Sleeve Gastrectomy Receives: Device: SmartPill in fasted state; Other: Aspiration; Other: Gastric emptying scintigraphy |
| Volunteers with obesity | Other | 6 obese volunteers Receives: Device: SmartPill in fasted state; Other: Aspiration; Other: Gastric emptying scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Temperature
Gastrointestinal Temperature (°C)
Measured: 0-7 days
Gastrointestinal pH
Gastrointestinal pH (pH values)
Measured: 0-7 days
Gastrointestinal Pressure
Gastrointestinal Pressure (mmHg)
Measured: 0-7 days
Concentration of bile acids
Concentration of bile acids
Measured: 1 day
Gastric emptying time
Gastric emptying time
Measured: 2 hours
Secondary outcomes (2)
Gastrointestinal motility
Contractions per minute
Measured: 0-7 days
Gastrointestinal transit times
Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Feb 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Van der Schueren, PhD, Principal investigator, UZ Leuven, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783052
- Sponsor's protocol ID
- S60930
- Acronym
- GASTON
- Status last verified
- Oct 2022
- First submitted
- 10 Aug 2018
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03783052
- Acronym / sponsor ID
- GASTON / S60930
- Conditions
- Obesity, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the years, obesity has become a major public health concern. The increasing rates of obesity are associated with an enhanced demand for weight-loss with bariatric surgery as a treatment option. Bariatric surgery procedures alter the anatomical structure of the gastrointestinal tract, which contributes to the postoperative weight loss. However, it is not sure how obesity and the anatomical alterations of bariatric surgery affect the gastrointestinal physiology including gastrointestinal pH, gastric emptying, intestinal transit time and concentration of enzymes.
Detailed description
During the visit in the obesity clinic, eligible patients will be approached for participation by the sub-investigator. Interested patients will receive information regarding the study and receive the information sheet containing the informed consent form. After signing the informed consent form, volunteers will be invited to come to the clinical research center:
- Healthy volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
- Obese volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
- Obese volunteers: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the stomach, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
- Volunteers after Sleeve Gastrectomy: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the sleeve, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
- Volunteers after Roux-en-Y gastric Bypass: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the pouch, the Roux limb and the common limb via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Device: SmartPill in fasted state, Device: SmartPill in fed state11 Healthy volunteers |
| Obese volunteers | Other | Device: SmartPill in fasted state, Device: SmartPill in fed state11 Obese Volunteers |
| Roux-en-Y Gastric Bypass patients | Other | Device: SmartPill in fasted state, Other: Aspiration, Other: Gastric emptying scintigraphy6 volunteers with a Roux-en-Y Gastric Bypass |
| Sleeve Gastrectomy patients | Other | Device: SmartPill in fasted state, Other: Aspiration, Other: Gastric emptying scintigraphy6 volunteers with a Sleeve Gastrectomy |
| Volunteers with obesity | Other | Device: SmartPill in fasted state, Other: Aspiration, Other: Gastric emptying scintigraphy6 obese volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (11 listed)
- History of gastric ulcers
- Disorders of swallowing
- Suspected strictures, fistulas or physiological GI obstruction.
- GI surgery within past three months
- Severe dysphagia to food or pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartPill in fasted stateSmartPill administration in fasted state | Device | Healthy volunteers, Obese volunteers, Roux-en-Y Gastric Bypass patients, Sleeve Gastrectomy patients, Volunteers with obesity |
| SmartPill in fed stateSmartPill administration in fed state | Device | Healthy volunteers, Obese volunteers |
| AspirationAspiration of gastrointestinal samples in fasted and fed state | Other | Roux-en-Y Gastric Bypass patients, Sleeve Gastrectomy patients, Volunteers with obesity |
| Gastric emptying scintigraphyGastric emptying scintigraphy in fed state | Other | Roux-en-Y Gastric Bypass patients, Sleeve Gastrectomy patients, Volunteers with obesity |
Primary outcome
Gastrointestinal Temperature
Time frame: 0-7 days
Gastrointestinal Temperature (°C)
Gastrointestinal pH
Time frame: 0-7 days
Gastrointestinal pH (pH values)
Gastrointestinal Pressure
Time frame: 0-7 days
Gastrointestinal Pressure (mmHg)
Concentration of bile acids
Time frame: 1 day
Concentration of bile acids
Gastric emptying time
Time frame: 2 hours
Gastric emptying time
2 secondary outcomes
Gastrointestinal motility
Time frame: 0-7 days
Gastrointestinal transit times
Time frame: 0-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Van der Schueren, PhD principal investigator
UZ Leuven, Department of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartPill in fasted state, SmartPill in fed state and Aspiration in people with Obesity and Bariatric Surgery Candidate, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Temperature (time frame: 0-7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.