NCT03109561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

April 6, 2017

Last Update Submit

July 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Indirect Calorimetry

    Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes

    4 hours

Secondary Outcomes (1)

  • Respiratory Quotient (RQ)

    4 hours

Other Outcomes (2)

  • Urea Nitrogen Output

    4 hours

  • Genotype

    4 hours

Interventions

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.

ApoEGENETIC

The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.

MetabolismDIAGNOSTIC_TEST

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.

Participants will be asked to follow simple instructions that are displayed on computer screen.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cognitively normal and are in good overall health.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 tablespoons of blood for DNA Testing

MeSH Terms

Interventions

Apolipoproteins EMetabolism

Intervention Hierarchy (Ancestors)

ApolipoproteinsLipoproteinsLipidsApoproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Lance Johnson1, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 12, 2017

Study Start

April 24, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations