Ignite Creation Date:
2024-05-06 @ 3:20 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02261688
Status:
TERMINATED
Last Update Posted:
2021-06-08
First Post:
2014-10-07
Brief Title:
Salt and TH-17 in Healthy Human Subjects
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Evaluation of the Influence of Salt Intake on TH17 InterleukinIL-17 Producing CD4 Helper T Cells in Human Subjects
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this study is to evaluate the association between sodium and TH17 cells in human subjects The subjects will have levels of TH-17 and various hormones measured on low salt diet low salt diet with intravenous normal saline and high salt diet
Detailed Description:
In recent years dietary sodium intake has dramatically increased and has been shown to play an active role in a number of detrimental diseases including hypertension and cardiovascular complications Additionally in the developed world there has been a steady increase in autoimmune diseases Type 17 helper T cells Th17 have been shown to play an active role in the development of autoimmune diseases
Serum glucocorticoid kinase SGK1 has been shown to influence sodium transport and salt homeostasis in many cell types Wulf J Clin Invest 2002 Salker Nature Med 2011 Prior in vitro and in vivo studies have shown that an increase in salt concentration in the media or dietary salt intake in mice induces SGK1 expression and enhances TH17 cell differentiation and worsens experimental autoimmune encephalomyelitis EAE animal model for multiple sclerosis Kleinewietfeld Nature 2013 Wu Nature 2013
The findings in this study can substantially increase the investigators understanding of environmental factors that modulate the development of autoimmunity in humans In animal models the worsening effects of a high salt diet on EAE are dramatic To the investigators knowledge the proposed study will be the first to determine if salt intake has the same adverse impact in humans If documented one could envision the development of a novel treatment approach for human autoimmunity via the regulation of salt intake Thus the overall goal of this study is to evaluate the association between sodium and TH17 cells in human subjects In addition to measuring TH17 cells by flow cytometry the investigators will also measure interleukins such as IL-17a IL-17f IL-23 that are important in TH17 differentiation and production
Serum glucocorticoid kinase SGK1 has been shown to influence sodium transport and salt homeostasis in many cell types Wulf J Clin Invest 2002 Salker Nature Med 2011 Prior in vitro and in vivo studies have shown that an increase in salt concentration in the media or dietary salt intake in mice induces SGK1 expression and enhances TH17 cell differentiation and worsens experimental autoimmune encephalomyelitis EAE animal model for multiple sclerosis Kleinewietfeld Nature 2013 Wu Nature 2013
The findings in this study can substantially increase the investigators understanding of environmental factors that modulate the development of autoimmunity in humans In animal models the worsening effects of a high salt diet on EAE are dramatic To the investigators knowledge the proposed study will be the first to determine if salt intake has the same adverse impact in humans If documented one could envision the development of a novel treatment approach for human autoimmunity via the regulation of salt intake Thus the overall goal of this study is to evaluate the association between sodium and TH17 cells in human subjects In addition to measuring TH17 cells by flow cytometry the investigators will also measure interleukins such as IL-17a IL-17f IL-23 that are important in TH17 differentiation and production
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None