Apolipoprotein E (ApoE) and Metabolism

Completed

• Conditions: Cognitive Function; Healthy

• Registration Number: NCT03109561
• Lead Sponsor: Lance Johnson

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.

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 Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2018-04-24
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Indirect Calorimetry	4 hours	Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes

Secondary Outcome Measures

Name	Time	Method
Respiratory Quotient (RQ)	4 hours	Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States