An interventional study of Infusion of a liquid meal intraduodenally in Postprandial Glucose Homeostasis, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Basic science
The aim of the study is to investigate and clarify whether the effect of IL-6 on glucose tolerance and insulin secretion are secondary to the changes in gastric emptying.
The literature provides no information regarding a role for interleukin-6 (IL-6) in the regulation of beta cell function (glucose or meal-stimulated insulin secretion) in humans. Previous studies infusing IL-6 into humans have primarily focused on insulin action and the effects on peripheral insulin sensitivity whereas a potential effect on insulin secretion has been neglected.
We have demonstrated that an acute increase in IL-6, obtained by a single bolus of IL-6, potentiated glucose-induced insulin secretion in a glucagon-like peptide-1 (GLP-1) dependent manner in mice1. In mice, IL-6 enhanced insulin secretion in a dose- and glucose-dependent manner, along with increasing concentrations of GLP-1. Interleukin-6 had no effect on insulin secretion in GLP-1 receptor knock-out mice or in mice treated with the GLP-1 receptor antagonist. Thus, in mice, GLP-1 has proven an essential mediator of IL-6 actions on beta cell function.
Importantly, a single bolus of IL-6 also significantly increased glucose-stimulated insulin secretion in several mouse models of obesity and diabetes (diet-induced obesity, the ob/ob and the db/db mouse).
Own data show that an infusion of IL-6 causes a significant delay in the rate of gastric emptying (GE) after a mixed meal in healthy young men. Data showed that this delay in GE is associated with much improved glucose tolerance and insulin secretion (unpublished data).
In the present study we wish to investigate whether the beneficial effects of IL-6 on postprandial glucose tolerance and insulin secretion are dependent on a delay in gastric emptying. We will bypass the ventricle and infuse a mixed meal directly into the duodenum of healthy young men.
This study has the potential to show that the known effect of IL-6 on postprandial glucose tolerance is dependent on a delayed GE.
Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Healthy young men will receive IL-6 infusion
Procedure: Infusion of a liquid meal intraduodenally
Healthy young men will receive saline infusion
Procedure: Infusion of a liquid meal intraduodenally
Infusion of IL-6/NaCL before a liquid meal intraduodenally
The paracetamol uptake
paracetamol blood levels (mmol/l) on both study days. The paracetamol absorbance will be compared between the 2 study days.
Time frame: 0-14 days
GLP-1 secretion
Active GLP-1 blood levels on both study days. The levels on the 2 study days will be compared.
Time frame: 0-14 days
Glucagon secretion
Glucagon blood levels on both study days. The levels on the 2 study days will be compared.
Time frame: 0-14 days
Insulin levels
Insulin blood levels on both study days. The levels on the 2 study days will be compared.
Time frame: 0-14
Glucose
Plasma glucose levels on both study days. The levels on the 2 study days will be compared.
Time frame: 0-14
Plan to share: No
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Rigshospitalet, Denmark