Effect of Rosiglitazone on In-vivo Angiogenic Potential of Human Adipose Tissue
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Adipose Tissue Capillary Sprout Formation
研究概览
简要总结
Insulin resistance is a common condition that can lead to type 2 diabetes. One of the commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this research is to see if rosiglitazone also increases blood vessel growth in human fat cells. The investigators will compare results from before and after being on rosiglitazone for 6 weeks.
详细描述
Adipocytes play a crucial role in the control of metabolic homeostasis, by sequestering excess calories in the form of triglycerides, and secreting cytokines that control systemic fuel utilization. Sustained excess calorie consumption results in adipocyte hypertrophy and hyperplasia, and like any expanding tissue, requires increased capillary expansion to nourish the enlarged adipose tissue mass. Recent reports indicate that decreased capillary density in adipose tissue of obese individuals correlates with insulin resistance, suggesting that an imbalance of angiogenesis and adipogenesis may underlie this condition. To determine whether improvement in insulin sensitivity is related to changes in adipose tissue capillary development, we conducted a randomized, double-blind, placebo-controlled trial to determine capillary density, angiogenic growth potential, and metabolic parameters in healthy human volunteers before and after treatment with rosiglitazone, a potent insulin sensitizer.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight but otherwise in good general health.
- •Age 18 - 55 years.
- •Normal glucose tolerance.
- •Stable weight with BMI (27-44).
- •Stable medication use for the preceding month.
- •Negative pregnancy test (*HCG), if female and of childbearing potential.
- •Practicing, and willing to continue to practice appropriate contraception throughout the study if a female of childbearing potential.
排除标准
- •Serious medical illness.
- •Tobacco use within the past 6 months.
- •Prior or current treatment with a thiazolidinedione.
- •Patients who have received an investigational drug in the past 30 days.
- •Use of systemic corticosteroids.
- •Known or suspected allergy to Rosiglitazone or any component of the preparation
研究组 & 干预措施
Rosiglitazone
One 8mg capsule daily for 6 weeks.
干预措施: Rosiglitazone (Drug)
Placebo
One capsule daily for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Adipose Tissue Capillary Sprout Formation
时间窗: 8 weeks
Adipose tissue collected at 8 weeks was cut into \~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.
次要结局
- Serum Adiponectin(8 weeks)
研究者
Samir Malkani
Study Principle Investigator
University of Massachusetts, Worcester