Apolipoprotein E (ApoE) and Metabolism
APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
1 active site
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
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedJuly 23, 2020
July 1, 2020
1.8 years
April 6, 2017
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.
The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.
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
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
- Lance Johnsonlead
Study Sites (1)
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Biospecimen
2 tablespoons of blood for DNA Testing
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lance Johnson1, PhD
University of Kentucky
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