Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
調査の概要
詳細な説明
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06519
- Yale School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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プラセボコンパレーター: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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flow mediated vasodilation (FMD)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠:2 hours
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SBP, measured in mmHg
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2 hours
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Diastolic Blood Pressure
時間枠:2 hours
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DBP, measured in mmHg
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2 hours
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serum total cholesterol
時間枠: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
時間枠: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)
時間枠: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])
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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plasma Catecholamines
時間枠: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])
時間枠: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])
時間枠: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])
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Nina Stachenfeld、Yale School of Medicine
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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