Status:
COMPLETED
Investigation of Acute Physiological Effects of Aspiration Therapy
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Obesity
Weight Loss
Eligibility:
All Genders
18-75 years
Brief 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 sub...
Detailed Description
It is generally agreed that the increasing incidence of obesity mainly is caused by the adoption of a sedentary lifestyle combined with excessive caloric intake. So far, preventive measures and interv...
Eligibility Criteria
Inclusion
- Patient who have had the Aspire Assist inserted (the aspiration therapy group)
- Age between 18-75 years
- Able to understand written patient information and sign informed consent
Exclusion
- Diagnosis of type 1 diabetes
- Severe comorbidities that, at the discretion of the investigators, exclude study participation (e.g. chronic obstructive pulmonary disease (COPD) stage III, significant cardiac arrhythmias etc.)
- Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
- Gastrointestinal conditions making the participant unsuitable for participation (e.g. ulcerative colitis, Crohn´s disease, clinically significant food allergies, candidiasis etc.)
- Anaemia with a haemoglobin value \<6.2 mmol/l (\<10 g/dl) for women and \<7.4 mmol/l (\< 12 g/dl) for men at time of screening
- Abuse of alcohol and/or drugs, or any other co-existing conditions that will make the participant unsuitable to attend to the study schedule, as deemed by the investigators
- Pregnancy or desire to become pregnant during the study period
- Exceptional conditions which, at the discretion of the investigators, preclude the participation in the study.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03389269
Start Date
March 1 2017
End Date
August 1 2018
Last Update
October 12 2018
Active Locations (1)
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1
Center for Diabetes Research
Hellerup, Denmark, 2900