NCT03783052

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

3.2 years

First QC Date

August 10, 2018

Last Update Submit

October 18, 2022

Conditions

ObesityBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (5)

  • Gastrointestinal Temperature

    Gastrointestinal Temperature (°C)

    0-7 days

  • Gastrointestinal pH

    Gastrointestinal pH (pH values)

    0-7 days

  • Gastrointestinal Pressure

    Gastrointestinal Pressure (mmHg)

    0-7 days

  • Concentration of bile acids

    Concentration of bile acids

    1 day

  • Gastric emptying time

    Gastric emptying time

    2 hours

Secondary Outcomes (2)

  • Gastrointestinal motility

    0-7 days

  • Gastrointestinal transit times

    0-7 days

Study Arms (5)

Healthy volunteers

OTHER

11 Healthy volunteers

Device: SmartPill in fasted stateDevice: SmartPill in fed state

Obese volunteers

OTHER

11 Obese Volunteers

Device: SmartPill in fasted stateDevice: SmartPill in fed state

Roux-en-Y Gastric Bypass patients

OTHER

6 volunteers with a Roux-en-Y Gastric Bypass

Device: SmartPill in fasted stateOther: AspirationOther: Gastric emptying scintigraphy

Sleeve Gastrectomy patients

OTHER

6 volunteers with a Sleeve Gastrectomy

Device: SmartPill in fasted stateOther: AspirationOther: Gastric emptying scintigraphy

Volunteers with obesity

OTHER

6 obese volunteers

Device: SmartPill in fasted stateOther: AspirationOther: Gastric emptying scintigraphy

Interventions

SmartPill in fasted stateDEVICE

SmartPill administration in fasted state

Healthy volunteersObese volunteersRoux-en-Y Gastric Bypass patientsSleeve Gastrectomy patientsVolunteers with obesity
SmartPill in fed stateDEVICE

SmartPill administration in fed state

Healthy volunteersObese volunteers
AspirationOTHER

Aspiration of gastrointestinal samples in fasted and fed state

Roux-en-Y Gastric Bypass patientsSleeve Gastrectomy patientsVolunteers with obesity
Gastric emptying scintigraphyOTHER

Gastric emptying scintigraphy in fed state

Roux-en-Y Gastric Bypass patientsSleeve Gastrectomy patientsVolunteers with obesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 18 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bart Van der Schueren, PhD

    UZ Leuven, Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

December 20, 2018

Study Start

February 1, 2018

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)