Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Study Details
Study Description
Brief Summary
Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Our scientific premise is that in AE-PCOS women, the androgen-dominant hormonal milieu causes BP increases via sympathetic activation, vasoconstriction and renal sympathetic nervous system activation. Moreover, this androgen-dominant milieu increases BP via activation of the renin-angiotensin system.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Healthy Control Healthy control participants. |
Drug: GnRH antagonist
GnRH antagonist up to 16 days.
Drug: GnRH antagonist + MethylTESTOSTERone 5 MG
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
|
Experimental: AE-PCOS Participants with AE-PCOS. |
Drug: GnRH antagonist
GnRH antagonist up to 16 days.
Drug: GnRH antagonist + MethylTESTOSTERone 5 MG
GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
|
Outcome Measures
Primary Outcome Measures
- Baroreflex assessment [Up to 3 months]
forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure
- Sympathetic response during LBNP [Up to 3 months]
Catecholamines
- Systolic blood pressure response to LBNP [Up to 3 months]
Beat by beat systolic blood pressure (Finometer)
- Diastolic blood pressure response to LBNP [Up to 3 months]
Beat by beat diastolic blood pressure (Finometer)
- Sympathetic Baroreflex Assessment [Up to 3 months]
Sympathetic Nerve activity (microneurography) during modified Oxford. Measured as MSNA as a function of diastolic blood pressure.
Secondary Outcome Measures
- Renal response to LBNP [Up to 3 months]
Plasma renin activity
- Paced Breathing [Up to 3 months]
Resting muscle sympathetic activity (MSNA) from nerves (microneurography in microvolts)
- Baroreflex response [Up to 3 months]
Valsalva Maneuver. Muscle sympathetic outflow from nerves during small blood pressure changes (microneurography in microvolts)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical Diagnosis of Polycystic Ovary Syndrome
-
Able to inject study drug
-
Able to swallow pills
Controls:
-Diagnosis of Insulin resistance
Exclusion Criteria:
-
Any woman that does not fit the inclusion criteria
-
Males
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The John B Pierce Laboratory | New Haven | Connecticut | United States | 06519 |
Sponsors and Collaborators
- Yale University
Investigators
- Principal Investigator: Nina Stachenfeld, PhD, Yale School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000020950