NCT00974272已完成4 期
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Carl T. Hayden VA Medical Center1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Triglyceride concentration in serum
研究概览
简要总结
The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT
- •Fasting triglyceride levels >140 and < 400 mg/dl and values varying less than 35% between two screening measurements
- •Normal liver function tests and white blood cell count
排除标准
- •Type 2 Diabetes for > 3 years or HbA1c ≥ 7.5
- •Known or suspected Type 1 Diabetes
- •Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin
- •Creatinine > 2.0 mg/dl or other evidence of active kidney disease
- •Hepatic enzyme elevation > 2x normal
- •Known Nonalcoholic Fatty Liver Disease
- •Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems
- •Recent history of nausea or vomiting
- •Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
- •A prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months
- •Current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day)
- •Any lipid lowering therapy in the prior 3 weeks other than a statin medication. Subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.
研究组 & 干预措施
Exenatide
Experimental
干预措施: Exenatide (Drug)
Placebo
Placebo Comparator
干预措施: Normal Saline (Other)
结局指标
主要结局
Triglyceride concentration in serum
时间窗: Before and up to 8-hours post-injection
次要结局
- serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function(Before and up to 8 hours post-injection)
研究者
研究点 (1)
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