NL-OMON49321已完成不适用
Consequences of (recurrent) hypoglycaemia on cardiovascular and inflammatory responses in patients with diabetes mellictus type 1, type 2 and healthy volunteers - HCIR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Overall inclusion criteria
- •* Ability to provide written informed consent
- •* Must be able to speak and read Danish (for Hillerød-site) and Dutch (for
- •Nijmegen-site)
- •* Insulin treatment according to basal-bolus insulin regimen (injections or
- •insulin pump) (except for group 5)
- •* Body-Mass Index: 19-40 kg/m2
- •* Age *18 years, * 75 years
- •* Blood pressure: <140/90 mmHg
- •* Duration of diabetes > 1 year (except for group 5)
- •* HbA1c < 100 mmol/mol, Group specific
- •* Group 1: HbA1c >64 mmol/mol
- •* Group 2: IAH as assessed by a score of *3 on the modified Clarke
- •questionnaire, *4 on the Gold questionnaires and a positive score on the
- •Pedersen-Bjergaard questionnaire.
- •* Group 3: NAH as assessed by a score of <3 on the modified Clarke
- •questionnaire, <4 on the Gold questionnaire and a negative score on the
- •Pedersen-Bjergaard.
- •* Group 4: Insulin treatment for at least 1 year and age*18 years, * 80 years
- •* Group 5: HbA1c <42 mmol/mol and age*18 years, * 80 years
- •Recurrent hypoglycaemia study
- •Healthy participants
- •- Ability to provide written informed consent
- •- Body-Mass Index: 19-40 kg/m2
- •- Age *16 years, * 75 years
- •- Blood pressure: <140/90 mmHg
排除标准
- •- Severe medical or psychological conditions interfering with the perception of
- •hypoglycaemia other than IAH such as brain injuries, epilepsy, a major
- •cardiovascular disease event or anxiety disorders
- •- Use of immune-modifying drugs or antibiotics
- •- Treatment with glucose-modifying (other than insulin, SGLT-2 inhibitors and
- •methformin) agents (e.g. prednisolon)
- •- Use of anti-depressive drugs
- •- Pregnancy or breastfeeding or unwillingness to undertake measures for birth
- •- Use of statins (e.g. stop statins >2 weeks before performing blood sampling.
- •This can be safely done in the context of primary prevention)
- •- Any event of cardiovascular disease in the past 5 years (e.g. myocardial
- •infarction, stroke, heart failure, symptomatic peripheral arterial disease)
- •- Auto-inflammatory or auto-immune diseases
- •- Any infection in past three months
- •- Previous vaccination in the past three months
- •- Laser coagulation for proliferative retinopathy in the past six months
- •- Proliferative retinopathy
- •- Diabetic nephropathy as reflected by an albumin-creatinine ratio * 30 mg/gor
- •an estimated glomerular filtration rate (by MDRD) *60ml/min/1.73m2
- •- History of pancreatitis (acute or chronic) or pancreatic cancer
研究者
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