EUCTR2017-002101-35-DK进行中（未招募）1 期
THE ROLE OF HYPERGLYCEMIA, HYPERINSULINEMIA AND ELEVATED FREE FATTY ACIDS FOR CARDIAC FUNCTION IN PATIENTS WITH TYPE 2 DIABETES – THE HYPERCARD2 STUDY - HyperCarD2
Sten Madsbad0 个研究点目标入组 20 人开始时间: 2017年6月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Elegible for inclusion are male patients aged =18 years with T2DM who are either drug naïve (no anti-diabetes agents for =12 weeks prior to randomization) with HbA1c =10.0% or taking any background anti-diabetes therapy (except insulin) with HbA1c =9.0% despite diet and exercise counseling.
- •6.1 INCLUSION CRITERIA:
- •Age = 18 years
- •BMI = 28 kg/m2
- •HbA1c = 9.0% (=10% in diet or metformin only treated patients)
- •Fasting C-peptide = 500 pmol/L
- •Unchanged antiglycemic treatment 12 weeks prior to inclusion as assessed by investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •EXCLUSION CRITERIA:
- •Insulin treatment within 3 months of informed consent
- •Type 1 diabetes
- •Psychiatric disorder or mental retardation
- •Drug or alcohol abuse within 3 months from informed consent
- •Poor compliance
- •Anemia (hgb = 6.4 mmol/L) or other blood dyscrasias causing hemolysis or unstable red blood cells
- •Indication of liver disease, defined by serum levels of alanine amininotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit
- •Impaired renal function (eGFR<45ml/min/1.73 m2)
- •Treatment with anti-obesity drugs 3 months prior to informed consent
- •Systemic steroid treatment within 6 weeks of informed consent
- •Uncontrolled thyroid disease (prescribed changes in thyroid medication within the 6 weeks prior to informed consent)
- •Any uncontrolled endocrine disorder except type 2 diabetes
- •Bariatric surgery or other gastrointestinal disorders that compromises gastrointestinal absorption
- •Peptic ulcer – verified by endoscopically
- •Any form of planned surgery within 3 months of informed consent
- •Acute coronary syndrome, stroke or TCI within 2 months prior to informed consent
- •Persistent atrial fibrillation
- •Inability to undergo experimental procedures including exclusion criteria for MRI scanning:
- •oImplantable cardioverter defibrillator/pacemaker
- •oFerromagnetic clips
- •oClaustrophobia.
- •Contraindication to glycopyrrolate infusion:
- •oKnown closed-angle glaucoma
- •oknown severe prostate hyperplasia
- •oTachycardia (HR > 100 at rest)
- •oKnown bladder atony
- •oCardia insufficiency or non-congenital pylorus stenosis – verified endoscopically
- •oKnown gastroparesis
- •Allergy towards any of the drugs or diagnostics used in the protocol (insulin, empagliflozin, acipimox, glycopyrrolate, adenosine, gadolinium contrast enhancer).
- •Any condition which in the opinion of the investigator may jeopardize subject safety or compliance with the protocol
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