Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

Brain Metabolism Clinical Trial

Official title:

Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357550
• Other study ID #: RM-1-10-72-106-14
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: January 15, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Sundhedsstyrelsen
• Study type: Interventional

Clinical Trial Summary

This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.

Hypotheses

1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.

2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.

3. Altered oxygen consumption during hyperketonemia in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy

• BMI 20-30 kg/m2

Exclusion Criteria:

• smoking

• alcohol abuse

• severe comorbidity

• blood donation 6 month prior

• claustrophobia

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Brain Metabolism
• Ketone Body Metabolism

Intervention

Drug:
• ketone
3-OHB is infused intravenously.
• placebo
Saline infusion.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose metabolism in brain, CMR	cerebral glucose metabolism measured by PET tracer during the above time frame	t=240-360 minutes	No
Secondary	Stress metabolism	growth hormone, cortisol, glucagon, adrenalin, ghrelin.	0-360 minutes	No
Secondary	Oxygen use	cerebral oxygen consumption measured by PET tracer during the above time frame	T=150-200 minutes	No
Secondary	cerebral blood flow	cerebral blood flow measured by PET tracer during the above time frame	t=180-250 minutes	No
Secondary	Intramuscular signaling	protein and insulin signaling in muscle	t= 260 minutes	No