Lipid Metabolism Clinical Trial
Official title:
The Role of Glucocorticoid Receptor SNPs in Receptor Function and Metabolic Disease
Background:
- Glucocorticoids are primary stress response hormones released from the adrenal gland when
an individual is under stress. Chronic or ongoing elevation of these hormones due to
prolonged stress or medical treatments can have numerous harmful effects. Researchers are
interested in learning more about how these hormones affect cell growth, development, and
death. To study glucocorticoid hormones, researchers plan to use the medication
dexamethasone, which affects the parts of cells that respond to glucocorticoid hormones.
Objectives:
- To study glucocorticoid stress hormones in healthy individuals before and after receiving
dexamethasone.
Eligibility:
- Healthy individuals at least 18 years of age.
- Participants must not be using certain medications that may affect the dexamethasone
test, including hormonal contraception, steroid-based drugs, and some antidepressants.
Design:
- This study will require an initial screening visit and a second study visit. The visits
are estimated to require about 1 to 2 hours of participation over a period of up to 14
days.
- Participants will be screened at visit 1 with a full physical examination and medical
history, and an initial blood sample for testing.
- For visit 2, participants will be asked to abstain from all food and drinks except for
water for 12 hours before the appointment, and will take one tablet of dexamethasone 9
hours before the appointment.
- Participants will have a second blood sample taken during visit 2, and will receive a
snack after the blood is drawn.
STUDY DESIGN:
This in vivo and in vitro observational gene association study will investigate the
functional relevance of SNPs in the NR3C1 gene in selected populations. A subgroup of the EPR
will be genotyped to identify novel SNPs in the NR3C1 gene. The most promising SNPs for
functional relevance in in vitro assays will be examined. Individuals with and without
functionally relevant, novel SNPs will be recruited for further study. In part 1, lymphocytes
from these participants will be isolated, exposed ex vivo to corticosteroids, and gene
expression profiles in response to this stimulus will be compared. In part 2, in vivo effect
of these SNPs in steroid responsiveness will be evaluated by performing a modified low dose
dexamethasone suppression test comparing by genotype. The study design is innovative as a
gene association study in the sense that participants are recruited on the basis of genotype
and then the phenotype of each participant is observed.
STUDY DURATION:
It is anticipated that the study will require 48 months to complete participants study
visits.
PRIMARY OBJECTIVE:
Investigate in vivo the role of hGR SNPs (hGR9beta A3669B, hGR N363S) in steroid
responsiveness by performing a modified dexamethasone suppression test and comparing
responses by genotype.
SECONDARY OBJECTIVE:
Investigate the role of hGR SNPs (hGR9beta A3669B, hGR N363S) in human steroid responsiveness
by comparing (across genotypes) gene expression profiles of isolated macrophages and
lymphocytes exposed ex vivo to corticosteroids.
PRIMARY ENDPOINT:
Measure the change in serum cortisol levels after modified dexamethasone suppression test.
SECONDARY ENDPOINT:
Measure gene expression fold changes by microarray analysis after ex vivo glucocorticoid
exposure of macrophages and lymphocytes; validation of affected RNA (elevated or decreased
expression) through PCR analysis.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT03689738 -
Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety
|
N/A | |
Completed |
NCT00905892 -
Metabolic Fate Modifications of Saturated Fats After an Overfeeding
|
N/A | |
Completed |
NCT03270527 -
RISSCI-1 Blood Cholesterol Response Study
|
N/A | |
Completed |
NCT01779245 -
Effect of High-calcium Intake on Substrate Metabolism During Exercise
|
N/A | |
Completed |
NCT03324191 -
Tea Extract, Blood Lipid and Dietary Fat
|
N/A | |
Completed |
NCT03757767 -
The Fasting Study - Unraveling the Mechanistic Effects of Prolonged Fasting in Humans.
|
N/A | |
Completed |
NCT05282641 -
Effects of 10-gram Collagen Protein Hydrolysate on Cardiometabolic Health
|
N/A | |
Completed |
NCT04748432 -
Lipid Kinetics of Patients With Pneumonia
|
||
Completed |
NCT03648112 -
Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
|
N/A | |
Recruiting |
NCT04851041 -
Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Cardiometabolic Health
|
N/A | |
Completed |
NCT05313594 -
Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses
|
||
Terminated |
NCT05297032 -
Effects of Quercetin on Metabolic Health
|
N/A | |
Completed |
NCT05297825 -
Twins Nutrition Study (TwiNS): Vegan vs. Omnivore
|
N/A | |
Recruiting |
NCT03287518 -
Evaluation of the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
|
N/A | |
Completed |
NCT00227500 -
Pravastatin for Hyperlipidaemia in HIV.
|
Phase 4 | |
Recruiting |
NCT04894526 -
Alternating Energy Intake and Blood Fat Content After a Meal
|
N/A | |
Completed |
NCT03029364 -
Body Composition and Lipid Metabolism at Rest and During Exercise: A Cross-Sectional Analysis.
|
||
Completed |
NCT01921075 -
Physiologic Plasticity of Intramyocardial Lipid Storage
|
N/A | |
Completed |
NCT00620360 -
Acute Effect of Fructose on Lipid Metabolism and Gender Differences
|
N/A |