Estrogen and Microvascular Function

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Recruiting

CT.gov ID

NCT06043310

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to learn how long-term use of estrogen affects blood vessels in healthy adults who were assigned male at birth.

Participants will:

give one blood draw of 5 mL
have a camera placed under the tongue to take pictures of blood vessels
have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion

Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.

Condition or Disease	Intervention/Treatment	Phase
Estrogen Cardiovascular Diseases Microvasculature	Drug: Nω-nitro-L-arginine methyl ester (L-NAME) Drug: Acetylcholine Drug: Sodium Nitroprusside

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Sex-specific Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Actual Study Start Date :

Jun 2, 2023

Anticipated Primary Completion Date :

Dec 1, 2029

Anticipated Study Completion Date :

Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
AMAB + continuous estrogen Identify as assigned male at birth (AMAB) who have had continuous estrogen treatment for a minimum of 1 year.	Drug: Nω-nitro-L-arginine methyl ester (L-NAME) L-NAME will be infused locally through microdialysis catheters. Drug: Acetylcholine ACh will be infused locally through microdialysis catheters. Drug: Sodium Nitroprusside SNP will be infused locally through microdialysis catheters.
AMAB - continuous estrogen Identify as assigned male at birth (AMAB) who have not had continuous estrogen treatment for a minimum of 1 year.	Drug: Nω-nitro-L-arginine methyl ester (L-NAME) L-NAME will be infused locally through microdialysis catheters. Drug: Acetylcholine ACh will be infused locally through microdialysis catheters. Drug: Sodium Nitroprusside SNP will be infused locally through microdialysis catheters.

Arm

Intervention/Treatment

AMAB + continuous estrogen

Identify as assigned male at birth (AMAB) who have had continuous estrogen treatment for a minimum of 1 year.

Drug: Nω-nitro-L-arginine methyl ester (L-NAME)

L-NAME will be infused locally through microdialysis catheters.

Drug: Acetylcholine

ACh will be infused locally through microdialysis catheters.

Drug: Sodium Nitroprusside

SNP will be infused locally through microdialysis catheters.

AMAB - continuous estrogen

Identify as assigned male at birth (AMAB) who have not had continuous estrogen treatment for a minimum of 1 year.

Drug: Nω-nitro-L-arginine methyl ester (L-NAME)

L-NAME will be infused locally through microdialysis catheters.

Drug: Acetylcholine

ACh will be infused locally through microdialysis catheters.

Drug: Sodium Nitroprusside

SNP will be infused locally through microdialysis catheters.

Outcome Measures

Primary Outcome Measures

Change in blood vessel dilation [2 hours]
Cutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.
Change in Perfused Vessel Density [0.5 hours]
Total vessel density (TVD) will be calculated using the DeBacker Score manual analysis on all images that have a minimum microcirculation image quality score (MIQS) of 10. Perfused vessel density (PVD) will be calculated by multiplying total vessel density (TVD) x proportion of perfused vessels (PPV%).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Inclusion Criteria:

Adults aged 18-60 years
Identify as assigned male at birth (AMAB) +/- continuous estrogen treatment for a minimum of 1 year.
Blood pressure <140/ < 90 mmHg
No more than 1 cardiovascular risk factor

Exclusion Criteria:

BMI >35
Medications that could alter cardiovascular control
Rash, skin disease, or pigmentation disorders
Anemia
Kidney Disease
Known skin allergies
Smoking or tobacco use within last 6 months
Coronary Artery Disease
1 cardiovascular risk factor
Hypertension
Diabetes
Hypercholesterolemia
Hyperlipidemia
Bleeding disorders
Use of anti-coagulants
Allergies to study drugs
Erectile dysfunction medication in the past 6 months
Use of topical/non-topical steroids in last 6 months
Internal mouth sores

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Froedtert Hospital	Wauwatosa	Wisconsin	United States	53226

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Julie K. Freed, Executive Vice Chair, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT06043310

Other Study ID Numbers:

PRO40920

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Julie K. Freed, Executive Vice Chair, Medical College of Wisconsin

Transgender

Hormone Replacement Therapy

Additional relevant MeSH terms:

Cardiovascular Diseases

Nitroprusside

Acetylcholine

Study Results

No Results Posted as of Sep 21, 2023