Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Flow-mediated Dilation From Baseline to 4 Hours
研究概览
简要总结
Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people.
详细描述
Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4 occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV) infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females
- •Obese subjects (body mass index (BMI) ≥ 30 kg/m^2)
- •18 and 65 years
- •Blood pressure reading < 140/80 mm Hg and no prior history of hypertension
排除标准
- •History of diabetes mellitus
- •History of hypertension
- •Fasting triglyceride levels > 250 mg/dL
- •Liver disease (ALT 2.5x > upper limit of normal)
- •Serum creatinine ≥1.5 mg/dL
- •Smokers, drug or alcohol abuse
- •Mental condition rendering the subject unable to understand the scope and possible consequences of the study
- •Female subjects who are pregnant or breast feeding
结局指标
主要结局
Change in Flow-mediated Dilation From Baseline to 4 Hours
时间窗: Baseline, 4 hours
Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.
Change in Systolic Blood Pressure From Baseline to 4 Hours
时间窗: Baseline, 4 hours
Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.
Change in Systolic Blood Pressure From Baseline to 8 Hours
时间窗: Baseline, 8 hours
Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.
Change in Diastolic Blood Pressure From Baseline to 4 Hours
时间窗: Baseline, 4 hours
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.
Change in Diastolic Blood Pressure From Baseline to 8 Hours
时间窗: Baseline, 8 hours
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.
次要结局
- Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours(Baseline, 4 hours)
- Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours(Baseline, 8 hours)
- Change in Triglyceride Levels From Baseline to 4 Hours(Baseline, 4 hours)
- Change in Triglyceride Levels From Baseline to 8 Hours(Baseline, 8 hours)
- Plasma Glucose Levels for Saline Infusion(Baseline, 4 hours, 8 hours)
- Plasma Glucose Levels for Intralipid Infusion(Baseline, 4 hours, 8 hours)
- Plasma Glucose Levels for Dextrose Infusion(Baseline, 4 hours, 8 hours)
- Plasma Glucose Levels for Intralipid/Dextrose Infusion(Baseline, 4 hours, 8 hours)
- Insulin Levels for Saline Infusion(Baseline, 4 hours, 8 hours)
- Insulin Levels for Intralipid Infusion(Baseline, 4 hours, 8 hours)
- Insulin Levels for Dextrose Infusion(Baseline, 4 hours, 8 hours)
- Insulin Levels for Intralipid/Dextrose Infusion(Baseline, 4 hours, 8 hours)
- C-peptides Levels for Saline Infusion(Baseline, 4 hours, 8 hours)
- C-peptides Levels for Intralipid Infusion(Baseline, 4 hours, 8 hours)
- C-peptides Levels for Dextrose Infusion(Baseline, 4 hours, 8 hours)
- C-peptides Levels for Intralipid/Dextrose Infusion(Baseline, 4 hours, 8 hours)
研究者
Guillermo Umpierrez
Professor
Emory University