Apolipoprotein E (ApoE) and Metabolism

July 21, 2020 updated by: Lance Johnson

APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

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

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cognitively normal and are in good overall health.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indirect Calorimetry
Time Frame: 4 hours
Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Quotient (RQ)
Time Frame: 4 hours
Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes
4 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urea Nitrogen Output
Time Frame: 4 hours
Improve RQ measure accuracy by determining urinary urea nitrogen output in collected urine samples from these subjects.
4 hours
Genotype
Time Frame: 4 hours
Genotype subjects using DNA isolated from collected blood samples.
4 hours

Collaborators and Investigators

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

Sponsor

Lance Johnson

Investigators

  • Principal Investigator: Lance Johnson1, PhD, University of Kentucky

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 (ACTUAL)

April 24, 2018

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 17-0202-F1G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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