Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from baseline the rate of production of IDL Apo B
研究概览
简要总结
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.
The information will:
- reveal what is not working properly
- make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning
This biomedical research will take place at the University Hospitals of DIJON and NANTES.
- 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
- The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
- Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
- Participation in the study will last 6 months and include 4 protocol visits.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persons who have provided written consent
- •type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
- •Stable treatment for 3 months
- •HbA1c between 7.5% and 10%
- •Age between 30 and 65 years
- •BMI between 25 and 35 kg/m²
- •Triglycerides < 300 mg/dl
- •Half of the patients being treated with statins
- •eGFR > 75 ml/min/1.73 m² at inclusion
排除标准
- •persons without national health insurance cover
- •patients treated with Insulin or a GLP-1 agonist
- •Patients under guardianship
- •patients treated with lipid-lowering drugs (except statins for 50% of patients)
- •kidney failure
- •liver failure or abnormal liver function ASAT or ALAT >3 x upper limit of normal
- •total bilirubin >2mg/dl
- •intestinal disease
- •serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
- •Pregnancy, breastfeeding
- •hypersensitivity to the active substance or to excipients
- •patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
- •patients treated with loop diuretics or thiazides
研究组 & 干预措施
Patients not treated with statins
干预措施: Dapagliflozin (Drug)
Patients not treated with statins
干预措施: Placebos (Drug)
Patients treated with statins
干预措施: Dapagliflozin (Drug)
Patients treated with statins
干预措施: Placebos (Drug)
结局指标
主要结局
Change from baseline the rate of production of IDL Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of LDL Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of HDL Apo A1
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of VLDL Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of IDL Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of LDL Apo B
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
时间窗: 15 days before treatment initiation, Day 0, Day 90 and Day 180
次要结局
未报告次要终点