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

January 15, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • BMI 20-30 kg/m2

Exclusion Criteria:

  • smoking
  • alcohol abuse
  • severe comorbidity
  • blood donation 6 month prior
  • claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Drug: placebo
Saline infusion.
Experimental: Hyperketonaemia
Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Drug: ketone
3-OHB is infused intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose metabolism in brain, CMR
Time Frame: t=240-360 minutes
cerebral glucose metabolism measured by PET tracer during the above time frame
t=240-360 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress metabolism
Time Frame: 0-360 minutes
growth hormone, cortisol, glucagon, adrenalin, ghrelin.
0-360 minutes
Oxygen use
Time Frame: T=150-200 minutes
cerebral oxygen consumption measured by PET tracer during the above time frame
T=150-200 minutes
cerebral blood flow
Time Frame: t=180-250 minutes
cerebral blood flow measured by PET tracer during the above time frame
t=180-250 minutes
Intramuscular signaling
Time Frame: t= 260 minutes
protein and insulin signaling in muscle
t= 260 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Mads Svart, MD, Aarhus University / Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • RM-1-10-72-106-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Metabolism

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe