- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04922424
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06519
- Yale School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Two groups (n=10 each) of subjects will be recruited to complete this study: 1) trans men between 18 and 35 years; 2) cisgender women between 18 and 35 years (Controls). They will have a body mass index (BMI) 18-30 kg·m-2. Our subjects will be matched on BMI and IR, using hemoglobin A1c and Homeostatic Model Assessment of Insulin Resistance technique (HOMA-IR) in order to isolate testosterone effects from other co-morbidities that may impact BP, sympathetic activity or endothelial function. Subjects will have HbA1c of 4-5.9% and a HOMA-IR of 0.5-1.4 to be included in the study. Subjects who smoke, have diabetes, or BP>140/90 will be excluded. Subjects will not be taking medications during the study, including any insulin sensitizing or CV medications.
Exclusion Criteria:
- Subjects with the following histories or conditions will be excluded from the study:
Gynecologic: a. current or past estrogen-dependent neoplasia, b. unexplained vaginal bleeding, c. history of uterine fibroids, d. current pregnancy, e. known or suspected breast or uterine cancer, f. partial or complete hysterectomy.
Cardiac: a. myocardial infarction, ventricular tachycardia or fibrillation, b. angina, c. valvular disease (mitral insufficiency or stenosis, aortic insufficiency or stenosis), d. congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea, e. current arrhythmias, f. prosthetic valves.
Pulmonary: a. current cigarette smokers, or pipe or cigar smokers, b. chronic obstructive pulmonary disease, c. adult asthma, d. dyspnea on exertion, e. current bronchitis, pneumonia, or tuberculosis, f. lung carcinoma, g. pulmonary embolus, h. deep vein thrombosis.
Vascular: a. claudications or history of peripheral vascular disease, b. abdominal or thoracic aortic aneurysm, or repair of same, c. cerebral aneurysm, vascular malformations, d. hypertension, systolic or diastolic, or strong family history of hypertension.
Gastrointestinal: a. GI malignancy, b. hepatitis or other liver disease, current, c. splenomegaly from any cause, d. Cholecystitis, e. current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's disease, f. previous gastrointestinal surgery.
Infectious Disease: any ongoing intercurrent infection. Hematologic/Oncologic: a. receiving chemotherapy or radiation therapy, b. any metastatic malignancy, c. anemia (hematocrit < 35), d. thrombocytopenia or thrombocytosis, e. neutropenia, f. hematologic malignancy, g. bleeding dyscrasia.
Neurologic: a. history of cerebral vascular accident with any neurologic sequels, b. uncontrolled seizures (e.g., more than 1 seizure/year), c. transient ischemic attacks, d. dementia, e. neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy.
Endocrine: a. diabetes mellitus, b. any untreated endocrinopathy. Renal: a. chronic renal diseases, b. any history of renal disease or impairment, c. current urinary tract infection.
Musculoskeletal: a. inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters), b. any history of pathologic fractures, including vertebral compression fractures.
Pharmacologic: a. any illegal drug use, b. alcohol use greater than an average of 4 oz/day over 30 days, c. coumadin or heparin use.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: atorvastatin
We are testing that the lipid sensitive statin, atorvastatin treatment will reduce low density lipoprotein cholesterone, sympathetic nerve activity, increase endothelium-dependent vasodilation and improve autonomic function in trans men, while having little impact on cis women.
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Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first.
We will include 30 days of washout between treatments to minimize any potential carryover effects.
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Comparatore placebo: Placebo
We are testing that the placebo will have little effect on low density lipoprotein cholesterone, sympathetic nerve activity, endothelium-dependent vasodilation, autonomic function in trans men or cis women.
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Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first.
We will include 30 days of washout between treatments to minimize any potential
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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flow mediated vasodilation (FMD)
Lasso di tempo: 30 minutes
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FMD measures endothelial function, measured in % change from baseline arterial diameter after release following a short period of occlusion occlusion.
The % change in diameter reflects the ability of the vessel to dilate in response to sheer stress induced by the flow following the release of occlusion.
This reflects the function of the endothelium, or release of nitric oxide.
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30 minutes
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Muscle Sympathetic Nerve activity (MSNA)
Lasso di tempo: 2 hours
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measured using microneurography and expressed in bursts/min or bursts/100 heart beats
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2 hours
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Cardiovagal baroreflex sensitivity (BRS)
Lasso di tempo: 2 hours
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This is determined as a function of change in R-R interval (from EKG) over systolic blood pressure during rest and regular breathing.
Expressed in Units.
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2 hours
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Mental Stress Test
Lasso di tempo: 10 minutes
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While measuring sympathetic nervous system activity (SNS) with microneurography, we ask the subject to count backwards from 200 by 7.
This increases SNS.
Measured in bursts/min or burst/100 heart beats
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10 minutes
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Voluntary Breath-Hold
Lasso di tempo: 10 minutes
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While measuring sympathetic nervous system activity (SNS) with microneurography, we ask the subject to hold breath as long as possible without straining.
The subject does this twice, with a break in between.
This increases SNS.
Measured in bursts/min or burst/100 heart beats
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10 minutes
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Systolic Blood Pressure
Lasso di tempo: 2 hours
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SBP, measured in mmHg
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2 hours
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Diastolic Blood Pressure
Lasso di tempo: 2 hours
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DBP, measured in mmHg
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2 hours
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serum total cholesterol
Lasso di tempo: 5 minutes
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Measured in ng/dl.
Elevated total cholesterol can indicate dyslipidemia.
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5 minutes
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serum low density lipoprotein (LDL)-C
Lasso di tempo: 5 minutes
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Measured in ng/dl.
Elevated LDL-C can indicate dyslipidemia
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5 minutes
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serum high density lipoprotein (HDL-C)
Lasso di tempo: 5 minutes
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Measured in ng/dl.
Low HDL-C can indicate dyslipidemia
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5 minutes
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plasma endothelin-1, (S[ET-1])
Lasso di tempo: 5 minutes
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endothelial health, increased ET-1 levels in the blood indicate damage to the endothelium
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5 minutes
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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plasma Catecholamines
Lasso di tempo: 5 minutes
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Measure of norepinephrine in pg/ml is a measure of whole body sympathetic nervous system outflow
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5 minutes
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serum estradiol (S[E2])
Lasso di tempo: 5 minutes
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estrogen is measured in pg/ml.
This should be suppressed in our trans subjects, and low in our cis subjects.
In the latter, low estrogen should indicate the early follicular phase of the menstrual cycle.
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5 minutes
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serum progesterone (S[P4])
Lasso di tempo: 5 minutes
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progesterone is measured in pg/ml.
This should be suppressed in our trans subjects, and low in our cis subjects.
In the latter, low progesterone should indicate the early follicular or ovulatory phases of the menstrual cycle.
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5 minutes
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serum sex hormone binding globulin (P[SHBG])
Lasso di tempo: 5 minutes
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measured in pg/ml.
This provides us with an indication of how much testosterone is free versus bound in the serum, and thus is available for biological function.
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5 minutes
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serum testosterone
Lasso di tempo: 5 minutes
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measured in pg/ml.
This indicates the level of testosterone in our trans men showing they are receiving treatment.
It should be high in our trans men and low in our cis women subjects.
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5 minutes
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plasma creatinine
Lasso di tempo: 5 minutes
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This is a measure of kidney function.
Important for blood pressure regulation
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5 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nina Stachenfeld, Yale School of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie metaboliche
- Disturbi del metabolismo lipidico
- Dislipidemie
- Iperlipidemie
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Antimetaboliti
- Agenti anticolesteremici
- Agenti ipolipidemizzanti
- Agenti regolatori dei lipidi
- Inibitori dell'idrossimetilglutaril-CoA reduttasi
- Atorvastatina
Altri numeri di identificazione dello studio
- 2000030176
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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