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Investigation of Acute Physiological Effects of Aspiration Therapy

NCT03389269 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2018-10-12

No results posted yet for this study

Summary

In the present study, the investigators aim to investigate postprandial physiology in patients who have had the Aspire Assist® inserted. This will involve a standardised mixed meal test (MMT) with subsequent aspiration of gastric content compared to MMT without aspiration. Furthermore, a comparison will be made between the aspiration group and a control group in order to evaluate whether continuous treatment with aspiration therapy affect the postprandial physiology. The primary outcomes of the trial are differences in postprandial plasma/serum glucose, insulin and gut hormone excursions during MMT with and without aspiration. Secondary outcomes encompass evaluation of satiety, gastric emptying and gallbladder motility following MMT with and without aspiration. Also, food intake during a subsequent ad libitum meal will be evaluated.

Conditions

Interventions

OTHER

Meal test

240 min mixed meal test with aspiration using AspireAssist.

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Filip K Knop, MD, Proff · Center for diabetes research, gentofte hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-08-01
Completion
2018-08-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389269 on ClinicalTrials.gov