Investigation of Acute Physiological Effects of Aspiration Therapy

NCT03389269 | Completed DMC

• 1 other identifier: H-16038453
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Plasma glucose concentration

  mmol/l, collected during mixed meal test and analysed by YSI STAT 2300

  0-240 min

Secondary Outcomes (16)

• Serum Insulin

  0-240 min

• plasma GLP-1

  0-240 min

• Indirect Calorimetry

  0-240 min

• Gallbladder volume

  0-240 min

• Ad libitum meal intake

  30 min

Study Arms (2)

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

Matched controls

Healthy, obese with BMI \> 27, the postprandial glucose metabolism will be tested with a meal test

Other: Meal test

Interventions

Meal test OTHER

240 min mixed meal test with aspiration using AspireAssist.

Matched controls; Obese patients treated with AspireAssist

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Diabetes Research

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gastric content postprandial. Plasma and serum. Urine.

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Filip K Knop, MD, Proff

  Center for diabetes research, gentofte hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, pH.D student

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: January 3, 2018
• Study Start: March 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)