Obesity Clinical Trial
Official title:
Investigation of Acute Physiological Effects of Aspiration Therapy
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.
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 interventions based on lifestyle modifications have not been able to affect the
western lifestyle to a degree that remedies the increasing prevalence of obesity. Likewise,
no medical interventions have yet been able to induce and maintain significant major weight
loss in obese populations. In contrast, bariatric surgery prompts a significant and often
sustained weight loss, which frequently triggers remission of obesity-related comorbidities.
However, bariatric surgery is invasive, irreversible and costly. Aspiration therapy was
introduced as a less invasive and cheaper treatment for obesity. According to some studies,
aspiration therapy is nearly as effective as Roux-en-Y gastric bypass in terms of excess
weight loss after one year. Thus, aspiration therapy may aspire as an alternative treatment
option for obesity with lower risk of complications than bariatric surgery.
The risk of developing impaired glucose tolerance and overt type 2 diabetes rises along with
increasing obesity. The estimated risk of developing type 2 diabetes increases 3-fold with a
body mass index (BMI) of 25-29.9 kg/m2 (overweight) and ~20-fold with a BMI >35 kg/m2
(severely obese) compared to a normal BMI (<25 kg/m2) (6). Type 2 diabetes is a complex,
multi-organ metabolic disorder and is associated with serious complications, reduced quality
of life and early death. The disease is characterized by hyperglycaemia and, thus, elevated
haemoglobinA1c (HbA1c) (>6.5% or >48mmol/mol), which is a blood parameter used clinically as
a measure of mean blood glucose over time (~3 months). Studies have shown that up to 70% of
the mean plasma glucose levels is caused by postprandial plasma glucose excursions. Moreover,
postprandial hyperglycaemia in itself seems to be associated with an elevated risk of
cardiovascular disease due to unfavourable effect on both small and large blood vessels.
Accordingly, postprandial hyperglycaemia has been suggested to constitute a better predictor
of mortality risk than fasting plasma glucose concentrations in both patients with type 2
diabetes and individuals with normal glucose tolerance. Since the prevalence of impaired
glucose tolerance is ~2-fold higher in obese compared to lean individuals, postprandial
hyperglycaemia poses a great risk of developing severe comorbidities such as cardiovascular
disease and type 2 diabetes for obese individuals and may increase mortality in this group.
It is yet unknown whether aspiration therapy can attenuate the plasma glucose response to a
meal. Due to the reduced amount of food reaching the intestine after aspiration, it seems
likely that aspiration therapy reduces postprandial plasma glucose excursions and thereby
prevents potential postprandial hyperglycaemia.
It is well known that an orally administered glucose load elicits a greater insulin secretion
response compared to an intravenous infusion of glucose resulting in identical plasma glucose
elevations. This phenomenon is called the incretin effect. The incretin effect is primarily
driven by the insulinotropic gut hormones glucagon-like peptide-1 (GLP-1) and
glucose-dependent insulinotropic polypeptide (GIP). These so-called incretin hormones play
crucial roles in regulation of glucose homeostasis and appetite. GLP-1 is produced in the
intestinal mucosa by the so-called enteroendocrine L cells, which are predominantly localised
in the distal part of the small intestine and the colon. GIP originates from enteroendocrine
K 5 cells in the gut mucosa. K cells are assumed to be predominant in the proximal part of
the small intestine. Both GLP-1 and GIP are secreted in response to ingestion of nutrients
and have strong glucose-dependent insulinotropic effects on pancreatic beta cells. The
incretin hormones are of interest in the present study, because impaired incretin effect is
an early sign of dysmetabolism in obese individuals and a distinctive feature of type 2
diabetes, suggesting that the impaired glucose tolerance of these patients is, at least in
part, due to a defective incretin system. Whether aspiration of gastric content after a meal
affects postprandial incretin hormone response has not been elucidated. The investigators
plan to investigate meal-induced incretin hormone excursions in plasma with and without
aspiration therapy and compare the results to a matched control group.
In addition to GLP-1 and GIP, several other gut-related hormones are known to regulate
glucose homeostasis and appetite. Glucagon is a peptide hormone secreted from the pancreatic
alpha cells. Glucagon acts opposite to insulin by promoting hepatic gluconeogenesis and
glycogenolysis causing increased plasma glucose concentrations. Oxyntomodulin and pancreatic
peptide YY3-36 (PYY) are peptide hormones secreted by the enteroendocrine L cells in response
to feeding and both suppress appetite. Gastrin is a hormone secreted by G cells localised in
the pyloric antrum, duodenum and pancreas. Gastrin stimulates acid (HCl) secretion and
gastric emptying by increasing gastric motility. Cholecystokinin (CCK) is a peptide hormone
secreted by the enteroendocrine I cells in the duodenum. CCK promotes bile release from the
gallbladder and also acts as an appetite suppressant. To this point, it is unknown how
aspiration therapy affects these appetite- and glucose-regulating hormones during a meal. The
investigators aim to investigate this during standardised mixed meal tests with and without
aspiration.
Furthermore, it is relevant to examine the effect of aspiration therapy on satiety. Thus, the
investigators aim to evaluate the effect of aspiration therapy on satiety before, during and
after a mixed meal as well as food intake after the MMT with and without aspiration evaluated
through an ad libitum meal provided at the end of the experimental days.
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