Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- IV infusion of nesiritide at a 3pmol/kg rate
研究概览
简要总结
The purpose of the study is to compare the effects of nesiritide to placebo administered by a continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy, obese, insulin resistant individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-65 years inclusive
- •Men and women
- •Able to provide written, informed consent
- •Weight stable (± 3 kg) during the 3 months prior to enrollment
- •BMI ≥ 30 kg/m2; body weight ≤ 106 kg
- •Resting blood pressure ≥ 110/60 mmHg and ≤ 150/100 mmHg
排除标准
- •Known coronary artery disease, angina or heart failure
- •Type 1 or Type 2 Diabetes (A1c ≥ 6.5% and/or fasting plasma glucose >125mg/dL)
- •Bleeding disorders
- •Hemoglobin level < 12.5 g/dL for women; < 13.0 g/dL for men
- •Acute or chronic infections
- •Hepatitis and/or cirrhosis (AST or Alanine Aminotransferase 2.5 times upper limit of normal)
- •Severe asthma or chronic obstructive pulmonary disease
- •Renal insufficiency (creatinine > 1.6 mg/dL)
- •Prior bariatric surgery
- •Inflammatory bowel disease or malabsorption
- •Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
- •Psychiatric or eating disorders
- •Untreated or inadequately controlled thyroid (abnormal TSH) or other endocrine disorders
- •Active rheumatoid arthritis or other inflammatory rheumatic disorder
- •Pregnant or nursing women
- •Presence of clinically significant abnormalities on electrocardiogram
- •Smoking (within the last 3 months)
- •Known hypersensitivity to nesiritide or any of its excipients
- •Poor intravenous access
- •Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phenteramine or other weight loss or anorectic agents.
研究组 & 干预措施
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
干预措施: Placebo (Drug)
Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
干预措施: Continous IV infusion of Nesiritide (Drug)
Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
干预措施: Hyperinsulinemic euglycemic clamp (Drug)
Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
干预措施: Placebo (Drug)
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
干预措施: Continous IV infusion of Nesiritide (Drug)
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
干预措施: Hyperinsulinemic euglycemic clamp (Drug)
结局指标
主要结局
IV infusion of nesiritide at a 3pmol/kg rate
时间窗: 48 hours
Average changes in glucose disposal rates (GDR) and endogenous glucose production (EGP) from baseline corrected for body weight at steady state of the clamp during the high- and low-dose portions.
次要结局
未报告次要终点