Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months
研究概览
简要总结
In an unbiased metabolomics approach with subsequent pathway analyses, the current study seeks to examine the effect of Liraglutide treatment on the metabolic signature in treated patients as well as the effect of Liraglutide on various echocardiographic parameters of cardiac function and rhythm profile, thus paving the way for future research to explain the effects of Liraglutide on cardiovascular mortality and overall mortality in treated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Serum levels of HbA1c ≥ 7,0%
- •Age ≥ 18 years
- •Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage III or chronic heart failure of NYHA II or III)
- •Written informed consent prior to study participation
排除标准
- •Type 1 diabetes
- •Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within the last 4 weeks
- •Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
- •Renal impairment (eGFR < 30 mL/min)
- •Occurrence of acute vascular events within 6 weeks before screening and randomization
- •Known or suspected hypersensitivity to Liraglutide
- •Pregnant females as determined by positive (serum or urine) hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
- •Lactating females
- •The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- •The subject received an investigational drug within 30 days prior to inclusion into this study.
- •The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
- •The subject is unwilling or unable to follow the procedures outlined in the protocol.
- •The subject is mentally or legally incapacitated.
研究组 & 干预措施
Liraglutide
Increasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen.
干预措施: Liraglutide Pen Injector [Victoza] (Drug)
Placebo
Matching Placebo once daily, subcutaneous injection via pre-filled pen.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months
时间窗: 3 month
Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months measured by a platform including 2 separate reverse phase (RP)/UPLC-MS/MS with positive ion mode electrospray ionization (ESI), (RP)/UPLC-MS/MS with negative ESI, and (HILIC)/UPLC-MS/MS with negative ESI.
次要结局
- change in left ventricular diastolic function(3 month)
- change in left ventricular systolic function(3 month)
- body weight(3 month)
- changes of serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, β-Hydroxybutyrate between Liraglutide treatment group and placebo group(3 month)
- Changes in systolic and diastolic blood pressure (mmHg)(3 month)
- Changes in NT-proBNP serum levels (pg/ml)(3 month)
- Differences of the serum lipid profile between Liraglutide treatment group and placebo group(3 month)
- Heart rate variability(3 month)
- Resting energy expenditure(3 month)
- Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group(3 month)
- Respiratory Exchange Ratio(3 month)
- Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group(3 month)
- Albumin excretion(3 month)
- changes in inflammasome analyses(3 month)