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Investigation of Acute Physiological Effects of Aspiration Therapy

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ClinicalTrials.gov Identifier: NCT03389269
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Christina Charlotte Nexoe-Larsen, University Hospital, Gentofte, Copenhagen

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 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.

Condition or disease Intervention/treatment
Obesity Weight Loss Other: Meal test

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 14 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Investigation of Acute Physiological Effects of Aspiration Therapy
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Group/Cohort Intervention/treatment
Obese patients treated with AspireAssist
Healthy, obese with BMI > 27, treated with AspireAssist for weight management, the postprandial glucose metabolism will be tested with a meal test
Other: Meal test
240 min mixed meal test with aspiration using AspireAssist.

Matched controls
Healthy, obese with BMI > 27, the postprandial glucose metabolism will be tested with a meal test
Other: Meal test
240 min mixed meal test with aspiration using AspireAssist.




Primary Outcome Measures :
  1. Plasma glucose concentration [ Time Frame: 0-240 min ]
    mmol/l, collected during mixed meal test and analysed by YSI STAT 2300


Secondary Outcome Measures :
  1. Serum Insulin [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  2. plasma GLP-1 [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  3. Indirect Calorimetry [ Time Frame: 0-240 min ]
    Resting metabolic rate measured by O2 consumption during mixed meal test

  4. Gallbladder volume [ Time Frame: 0-240 min ]
    Measured during mixed meal test by UL and calculated by this equation: π/6*D1*D2*D3/1000, D1 = longitudinal diameter, D2 = cross section width, D3 = cross sectional width

  5. Ad libitum meal intake [ Time Frame: 30 min ]
    post meal test

  6. Appetite [ Time Frame: 0-240 min ]
    Evaluated by visual analogue scale (VAS 0-10, where 0 is no appetite and 10 is very hungry) during mixed meal test

  7. Plasma GLP-2 [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  8. Plasma GIP [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  9. Plasma Glucagon [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  10. Plasma PYY [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  11. Plasma Oxyntomodulin [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  12. plasma ghrelin [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  13. Plasma acetaminophen [ Time Frame: 0-240 min ]
    mmol/L, Collected during mixed meal test

  14. plasma c-peptide [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  15. Plasma CCK [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test

  16. plasma gastrin [ Time Frame: 0-240 min ]
    pmol/l, Collected during mixed meal test


Biospecimen Retention:   Samples Without DNA
Gastric content postprandial. Plasma and serum. Urine.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
It is planned to recruit up to 25 patients who have had the Aspire Assist inserted. Furthermore, 10 healthy control participants matched for age, weight, height, BMI and sex will be recruited
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389269


Locations
Denmark
Center for Diabetes Research
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Filip K Knop, MD, Proff Center for diabetes research, gentofte hospital

Responsible Party: Christina Charlotte Nexoe-Larsen, MD, pH.D student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03389269     History of Changes
Other Study ID Numbers: H-16038453
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms