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临床试验/NCT06424756
NCT06424756
招募中
2 期

Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults

University of Georgia1 个研究点 分布在 1 个国家目标入组 60 人2024年7月1日

概览

阶段
2 期
干预措施
Placebo
疾病 / 适应症
Healthy
发起方
University of Georgia
入组人数
60
试验地点
1
主要终点
Cutaneous microvascular responses to local heating
状态
招募中
最后更新
去年

概览

简要总结

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially predisposing them to the development of hypertension and CVD. This study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy NHB adults.

注册库
clinicaltrials.gov
开始日期
2024年7月1日
结束日期
2030年3月31日
最后更新
去年
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

S. Tony Wolf

Assistant Professor

University of Georgia

入排标准

入选标准

  • Self-identify as either non-Hispanic Black or non-Hispanic White.
  • Men and women 18-75 years old.
  • Non-hypertensive (systolic blood pressure \[SBP\]\<130 and diastolic blood pressure \[DBP\] \<85 mmHg).
  • Have low density lipoprotein cholesterol \<150mg/dl.
  • Have HbA1C \<6.0%.

排除标准

  • Rash, skin disease, or disorders of pigmentation (e.g., psoriasis, eczema, vitiligo, or other skin inflammatory skin disorders)
  • Known skin allergies to latex or adhesives
  • Smoking and/or use of nicotine-containing products within the past year
  • Use of illegal/recreational drugs
  • Generalized kidney disease
  • Taking chloramphenicol, cholestyramine, medication for seizures, methotrexate, nitrofurantoin, tetracycline, barbiturates, steroids, phenobarbital/phenytoin, orlistat or pyrimethamine
  • Any current medications which could conceivably alter the cardiovascular control or responses
  • Diagnosed or suspected metabolic or cardiovascular disease
  • Current pregnancy or breastfeeding
  • History of skin or other cancers

研究组 & 干预措施

Placebo, then MitoQ

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

干预措施: Placebo

MitoQ, then Placebo

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

干预措施: MitoQ

MitoQ, then Placebo

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

干预措施: Placebo

MitoQ, then Placebo

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

干预措施: MitoTempo

MitoQ, then Placebo

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

干预措施: Tempol

MitoQ, then Placebo

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

干预措施: L-NAME

MitoQ, then Placebo

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

干预措施: SNP - Sodium Nitroprusside

Placebo, then MitoQ

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

干预措施: MitoQ

Placebo, then MitoQ

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

干预措施: MitoTempo

Placebo, then MitoQ

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

干预措施: Tempol

Placebo, then MitoQ

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

干预措施: L-NAME

Placebo, then MitoQ

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

干预措施: SNP - Sodium Nitroprusside

结局指标

主要结局

Cutaneous microvascular responses to local heating

时间窗: 1 hour post intervention

Using intradermal microdialysis, skin blood vessels will be locally treated with a mitochondria-targeted antioxidant (MitoTempo; 1 mM concentration). Nitric oxide (NO)-mediated skin vasodilation will be quantified via local inhibition of endothelial NO synthase during the course of the local skin heating protocol using L-NAME (15 mM concentration). Finally, maximal skin blood flow will be measured by heating the local area of skin to 43 degrees Celsius and locally perfusing sodium nitroprusside (SNP; an NO donor; 28 mM concentration). Two (2) thin fiber optic laser Doppler flowmeter probes and their holders, containing local heaters, will be used to measure skin blood flow.

Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)

时间窗: 1 hour post intervention

Blood will be drawn for isolation of PBMCs and measurement of mitochondrial function and oxidative stress production.

Flow-mediated dilation responses

时间窗: 1 hour post intervention

FMD measures the health of blood vessels. The ultrasound makes sound waves to measure the size of blood vessels and the speed of the blood during rest and occlusion. The cuff is inflated to 220 mmHg (a commonly-used suprasystolic pressure; i.e., arterial blood flow is completely occluded) for 5 minutes to stop blood flow to and from the forearm.

研究点 (1)

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