A Phase 4 interventional study of intransal insulin and Placebo in Diabetes, sponsored by German Diabetes Center. Completed at 1 site in Germany. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by German Diabetes Center · Phase 4, Interventional, and Treatment
Insulin has a direct effect on the energy metabolism of the brain under basal conditions and has an effect on the hepatic glucose production, lipid metabolism and the secretion of various hormone. The effect of intranasal insulin on peripheral metabolism in humans supposedly is mediated by the vagus nerve.
The purpose of this study is to determine whether central insulin influences the human peripheral insulin sensitivity of liver and muscle and whether vagus nerve stimulation can mimick this effect.
Insulin has a direct effect on the energy metabolism of the brain under basal conditions and has an effect on the hepatic glucose production, lipid metabolism in the mouse model.
The purpose of this study is to determine whether central insulin influences the human peripheral insulin sensitivity of liver and muscle and energy metabolism. Intranasal insulin can be used in humans to deliver insulin to the brain and studies have shown that intranasal insulin might reduce food intake, lower body weight and modulate muscle glucose and adipose tissue lipid metabolism in himans. These effects are likely mediated by the vagus nerve as skeletal muscle insulin sensitization after intranasal insulin relates to parasympathetic tone activity (Heni et al. Diabetes 2014). Transcutaneous auricular vagus nerve stimulation (taVNS) activates non-invasively the sensory branches of the vagus nerve and is applied in humans as adjuvant treatment in drug-resistant epilepsy (Frangos et al. 2015). Thereby it can be used to examine whether the vagus nerve indeed mediates brain insulin signals to the periphery.
Here we aim to investigate the effects of intranasal insulin on hepatic glucose, lipid and energy metabolism. We further aim to test whether taVNS can mimick intranasal insulin effects on peripheral metabolism in humans.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →German Diabetes Center is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intranasal insulin is applied to diabetic patients under fasting conditions
Drug: intransal insulin
intranasal insulin is applied to healthy patients under fasting conditions
Drug: intransal insulin
placebo spray is applied intranasally in type 2 diabetes patients under fasting conditions
Drug: Placebo
placebo spray is applied intranasally in healthy participants under fasting conditions
Drug: Placebo
Transcutanoues auricular vagus nerve stimulation is applied for 14 min in the external ear in healthy participants
Device: taVNS
Sham stimulation in the ear lobe is applied for 14 min in healthy participants
Device: sham stimulation
4x 40mU intranasal insulin
Also known as: intranasal insulin
Also known as: intranasal placebo spray
Also known as: transcutaneous auricular vagus nerve stimulation
Also known as: sham stimulation in the ear lobe
Insulin sensitivity
Assessment of insulin sensitivity with gold standard methods
Time frame: 6 months
Energy metabolism
Energy metabolism is assessed from gold standard methods
Time frame: 6 months
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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German Diabetes Center