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OpenTrials
Completed

NCT Number: NCT03783052

Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years or older

Exclusion criteria

  • 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
  • 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

Treatment and study plan

SmartPill in fasted state

Device

SmartPill administration in fasted state

SmartPill in fed state

Device

SmartPill administration in fed state

Aspiration

Other

Aspiration of gastrointestinal samples in fasted and fed state

Gastric emptying scintigraphy

Other

Gastric emptying scintigraphy in fed state

Primary outcomes

  1. Gastrointestinal Temperature

    Time frame: 0-7 days

    Gastrointestinal Temperature (°C)

  2. Gastrointestinal pH

    Time frame: 0-7 days

    Gastrointestinal pH (pH values)

  3. Gastrointestinal Pressure

    Time frame: 0-7 days

    Gastrointestinal Pressure (mmHg)

  4. Concentration of bile acids

    Time frame: 1 day

    Concentration of bile acids

  5. Gastric emptying time

    Time frame: 2 hours

    Gastric emptying time

Secondary outcomes

  1. Gastrointestinal motility

    Time frame: 0-7 days

    Contractions per minute

  2. Gastrointestinal transit times

    Time frame: 0-7 days

    Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: GASTON

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2018
Registry last updated
Oct 19, 2022

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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