NCT03657537

Effects of Ketone Bodies on Cognition in Type 2 Diabetes

KETOCOGNITION - Effects of Ketone Bodies on Cognition in Type 2 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Diabetes negatively affects cognition and increases the risk of developing overt dementia. Decreased cerebral glucose metabolism may be contributing to this effect, thus providing a glucose substitute using ketone bodies might improve neuronal function. In this study the investigators propose to provide quantitative results on cognitive performance during acute hyperketonemia in patients with type 2 diabetes.

Detailed description

It has been proposed that hypometabolism in the brain contributes to the neuropathology that leads to Alzheimer's disease (AD). Additionally cognitive disturbances in patients with AD are associated with and paralleled by a decrease in cerebral glucose metabolism. This AD-like reduction in cerebral metabolism has also been associated with insulin-resistance, and may contribute to one of the links between diabetes and AD. Therefore manipulating neuro-energetics by providing a glucose substitute seems to be a means of improving neuronal function. Here the investigators will examine the effect of ketone bodies on cognitive performance in patients with type 2 diabetes by a randomized cross-over trial. Each subject will meet for two experimental visits separated by 2-6 weeks. During the two visit days subjects will, in a randomized order, receive ketone bodies (β-hydroxybutyrate) or placebo (saline) intravenously. On both test days plasma glucose levels will be clamped. After glucose levels have been stabilized cognitive performance will be assessed by a battery of validated cognitive tests.

Conditions

• Type2 Diabetes
• Ketonemia
• Cognitive Change

Interventions

Type	Name	Description
DRUG	Ketone infusion	β-hydroxybutyrate is infused intravenously.
DRUG	Saline infusion	saline is infused intravenously.

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2018-09-05
• Last updated: 2019-02-20

Locations

1 site across 1 country: Denmark