Obesity Clinical Trial
Official title:
Investigation of Acute Physiological Effects of Aspiration Therapy
NCT number | NCT03389269 |
Other study ID # | H-16038453 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | August 1, 2018 |
Verified date | October 2018 |
Source | University Hospital, Gentofte, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | August 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Diabetes Research | Hellerup |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma glucose concentration | mmol/l, collected during mixed meal test and analysed by YSI STAT 2300 | 0-240 min | |
Secondary | Serum Insulin | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | plasma GLP-1 | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Indirect Calorimetry | Resting metabolic rate measured by O2 consumption during mixed meal test | 0-240 min | |
Secondary | Gallbladder volume | Measured during mixed meal test by UL and calculated by this equation: p/6*D1*D2*D3/1000, D1 = longitudinal diameter, D2 = cross section width, D3 = cross sectional width | 0-240 min | |
Secondary | Ad libitum meal intake | post meal test | 30 min | |
Secondary | Appetite | Evaluated by visual analogue scale (VAS 0-10, where 0 is no appetite and 10 is very hungry) during mixed meal test | 0-240 min | |
Secondary | Plasma GLP-2 | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Plasma GIP | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Plasma Glucagon | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Plasma PYY | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Plasma Oxyntomodulin | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | plasma ghrelin | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Plasma acetaminophen | mmol/L, Collected during mixed meal test | 0-240 min | |
Secondary | plasma c-peptide | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | Plasma CCK | pmol/l, Collected during mixed meal test | 0-240 min | |
Secondary | plasma gastrin | pmol/l, Collected during mixed meal test | 0-240 min |
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