Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference between baseline and peak serum LPS
研究概览
简要总结
This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes. The investigators will measure systemic endotoxin level and lipid level after ingestion of high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic endotoxemia and lipemia induced by high fat diet.
详细描述
Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment and 2 weeks of wash out period, all subjects will be switched to the opposite arm.
The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of 1st treatment, end of 1st treatment and end of 2nd treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to 75
- •At least 6 months from the diagnosis of type 2 diabetes
- •Current diabetes treatment: life style modification and/or metformin and/or sulfornylurea
- •No change of the diabetes treatment (drug number and dossage) in recent 3 months
- •HbA1c 6.5% to 10%
排除标准
- •Recent cardiovascular event in 6 months
- •Concurrent use of statin or fibrate or ezetimibe
- •Renal failure, chronic liver disease
- •Pregnancy or lactation
- •Use of other DPP-4 inhibitor or GLP-1 analogue in recent 3 months
研究组 & 干预措施
Gemigliptin
Gemigliptin 50mg qd added to subjects current diabetes treatment
干预措施: Gemigliptin (Drug)
Placebo
Placebo (identical in appearance to gemigliptin)
干预措施: Placebo (Drug)
结局指标
主要结局
Difference between baseline and peak serum LPS
时间窗: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet
The increment of serum LPS after ingestion of high fat diet
次要结局
- Fasting serum LPS level(After 10 hrs of fasting)
- Incremental AUC of serum LPS during oral fat tolerance test(serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet)
- Difference between baseline and peak serum triglyceride level(serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet)
- Incremental AUC of serum triglyceride level during oral fat tolerance test(serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet)
- Difference between baseline and peak serum apolipoprotein-B48(serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet)
- Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test(serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet)
- Serum level of inflammatory markers (CRP, TNF-alpha, IL-6)(After 10 hr of fasting)
- mRNA expression level of inflammatory markers in the adipose tissue(After high fat diet ingestion)