Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922424
Status:
WITHDRAWN
Last Update Posted:
2022-11-03
First Post:
2021-06-04
Brief Title:
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gender-identity differences are becoming increasingly diagnosed in the US and treatment with gender-affirming hormone therapy GAHT is associated with improved mental health outcomes However GAHT has been associated with cardiovascular risk in adult transgender patients although mechanisms and treatments have not been explored Understanding the cardiovascular effects and exploring the potential of a lipid sensitive statin as a potential treatment is important to optimizing safe treatment strategies for transgender men in mitigating this modifiable risk factor and designing and implementing effective interventions
Detailed Description:
In the US approximately 14 million men identify as transgender a number that is likely to increase with greater recognition of this condition Gender affirming hormone therapy GAHT which attempts to more align the physical appearance with the identified gender is the primary medical intervention for transgender people and is recognized as medically necessary GAHT has been associated with increased cardiovascular risk increased blood pressure dyslipidemia and endothelial dysfunction in transgender men receiving androgens however little is known about the mechanisms for these changes and few interventions have been proposed We hypothesize that the altered hormonal milieu is the major driver of increased cardiovascular risk in trans men and the initiation of testosterone will have effects on lipid profiles blood pressure and endothelial function In addition androgen exposure within the female vascular system is associated with sympathetic nervous system dysregulation We propose this dysregulation is mediated through rapid dyslipidemia associated with GAHT in trans men receiving androgens The first aim of this proposal is to test the hypothesis that testosterone treatment in trans men increases sympathetic activation blood pressure and endothelial dysfunction Recent studies have demonstrated that vascular endothelial cells are crucial to the pathogenesis of inflammatory disease Thus the cholesterol lowering effects of certain statins appear to be mediated in part by their action on the endothelium Important to these studies HMG-CoA reductase inhibitors ie lipid dependent statins not only lower LDL-C but improve both central sympathetic and peripheral microvascular function Therefore our second aim is to test the hypothesis that lipid dependent statin therapy will decrease sympathetic activation and improve endothelial function in trans men taking GAHT indicating that the increased sympathetic activity and endothelial dysfunction are mediated by the increased LDL-C with androgens Trans men undergoing GAHT and cisgender female controls will be examined twice at baseline and again following 30 days of treatment with the lipid dependent statin atorvastatin in a randomized cross over design Using microneurography measures of sympathetic nerve activity SNA in response to stressors will be quantified and analyzed within- and between groups and cardiovascular metrics including beat to beat blood pressure and conduit-level endothelial function will be assessed at baseline and with atorvastatin treatment These novel and innovative studies will illuminate the sympathetic and vascular changes that accompany GAHT and our atorvastatin intervention will provide insight into the mechanism for these changes as well as provide a method to reduce these risks in trans men undergoing GAHT This is a critical gap in our knowledge once these early changes can be identified and quantified subsequent studies can track these changes over longer trajectories of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None