NCT01329744终止1 期
Effects of Recombinant IGF-I in HIV Associated Metabolic Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.
详细描述
The main objectives of this study are the following:
- Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome.
- Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy.
- Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive with undetectable viral load
- •No change in antiretrovirals for 3 months
- •Evidence of lipoatrophy in the limbs, and face or gluteal area
- •Dyslipidemia defined as:
- •Fasting triglycerides > 200 OR
- •HDL cholesterol < 40 mg/dL
- •Abnormal glucose homeostasis defined as:
- •Fasting hyperinsulinemia > 20 uU/mL OR
- •Fasting glucose 100-125 mg/dL, inclusive
排除标准
- •Two consecutive viral >75 or > 50 copies/mL using the tests listed above
- •Presence of AIDS wasting
- •Change in antiretroviral medication (not dose) in the prior 3 months
- •Coronary artery disease, cerebrovascular, or peripheral arterial disease
- •Diabetes mellitus
- •Adrenal insufficiency, hypoglycemia, thyroid disease, or other endocrine disorder that is untreated
- •Malignancy
- •Eating disorder
- •Pregnancy (urine pregnancy test is required of all females)
- •Previous liposuction or bariatric surgery
- •Other systemic conditions or other disorders at the discretion of the investigators
- •Current use of systemic glucocorticoids, or other agent affecting body weight or glucose homeostasis or other drug at the discretion of the investigators
- •Use of interferon within the past six months
- •Use of insulin, insulin secretagogue, thiazolidinedione, or metformin in the prior 3 months
- •Initiation or dose adjustment, within the prior 3 months, of any of the following drugs or drug classes: fibrate, cholesterol binding resin, statin, niacin, or omega 3 fatty acid (fish oil).
- •Use of uridine, growth hormone, IGF-I, and growth hormone releasing factor analogues
研究组 & 干预措施
Treatment
Experimental
Recombinant IGF-I
干预措施: mecasermin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo control (Drug)
结局指标
主要结局
Body composition
时间窗: 24 weeks
Participants will have a body scan called a dual energy x-ray absorptiometry (DEXA) scan and a single slice abdominal CT scan and mid thigh scan to measure subcutaneous and internal fat.
次要结局
- Glucose Homeostasis(24 weeks)
研究者
Roy Kim
Assistant Professor
University of Texas Southwestern Medical Center
研究点 (1)
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