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Apolipoprotein E (ApoE) and Metabolism

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ClinicalTrials.gov Identifier: NCT03109561
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Lance Johnson, University of Kentucky

Brief Summary:
Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.

Condition or disease Intervention/treatment
Cognitive Function Healthy Other: Resting State Indirect Calorimetry Genetic: ApoE Diagnostic Test: Metabolism Other: Cognitive Challenge

Detailed Description:

The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.

To more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).

To determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood.


Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Intervention Details:
  • Other: Resting State Indirect Calorimetry
    The investigator will measure the amount of oxygen participants breathe in and the amount of carbon dioxide they breathe out using a portable unit. Participants will be asked wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.
  • Genetic: ApoE
    The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.
  • Diagnostic Test: Metabolism
    To more accurately measure the amount of carbohydrates, fats and proteins that the participants bodies metabolize, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study). The total amount of urine to be collected is approximately 4 teaspoons.
  • Other: Cognitive Challenge
    Participants will be asked to follow simple instructions that are displayed on computer screen.


Primary Outcome Measures :
  1. Indirect Calorimetry [ Time Frame: 4 hours ]
    Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes


Secondary Outcome Measures :
  1. Respiratory Quotient (RQ) [ Time Frame: 4 hours ]
    Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes


Other Outcome Measures:
  1. Urea Nitrogen Output [ Time Frame: 4 hours ]
    Improve RQ measure accuracy by determining urinary urea nitrogen output in collected urine samples from these subjects.

  2. Genotype [ Time Frame: 4 hours ]
    Genotype subjects using DNA isolated from collected blood samples.


Biospecimen Retention:   Samples With DNA
2 tablespoons of blood for DNA Testing


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Cognitively normal and are in good overall health.
Criteria

Inclusion Criteria:

  • all races/ethnicities
  • ages 18-65
  • cognitively normal
  • good health

Exclusion Criteria:

  • pregnant or breastfeeding.
  • have a bleeding disorder,
  • have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.
  • have a history of alcoholism or drug abuse
  • have a history of schizophrenia or currently suffer from bipolar disorder or major depression.
  • have vision or hearing loss severe enough to interfere with cognitive testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109561


Contacts
Contact: Lance Johnson, PhD 8593232146 Johnson.Lance@uky.edu

Locations
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lance Johnson, PhD    859-323-2746    Johnson.Lance@uky.edu   
Sponsors and Collaborators
Lance Johnson
Investigators
Principal Investigator: Lance Johnson1, PhD University of Kentucky

Responsible Party: Lance Johnson, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03109561     History of Changes
Other Study ID Numbers: 17-0202-F1G
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No