2024-519562-48-00招募中2 期
Desferal administration to improve the impaired reaction to hypoxia in diabetes (DESIRED) - A randomised, double-blind, placebo-controlled, cross-over study.
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Endothelial Precursor Cells in 10 ml blood after intermittent hypoxia exposure
研究概览
简要总结
To investigate whether systemic administration of deferoxamine can improve the response to hypoxic challenge in patients with diabetes mellitus type 1.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes mellitus type 1 with a duration of the disease between 5 and 40 years
- •HbA1c 55-100 mmol/mol
- •Normal ECG result, showing no signs of significant cardiac disorders
- •Contraception: Female subjects must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), use a highly effective method of contraception during the study and for 30 days after the last visit. Highly effective methods of contraception are considered to be those listed below: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; or progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine device; or intrauterine hormonereleasing system; or bilateral tubal occlusion; or vasectomised partner; or sexual abstinence
- •Signed informed consent
排除标准
- •Major cardiovascular complications such as coronary heart disease, unstable or stable angina, myocardial infarction, ventricular XML File Identifier: GVRsEn/+aiS1r4rVgVsURkq36HM= Page 11/21 arrhythmias, and atrial fibrillation in the last 3 months
- •Definite cardiovascular autonomic dysfunction
- •History of anemia, bleeding gastric ulcer, abundant menstruation
- •Currently smoking
- •History of alcohol or drug abuse
- •Infections that necessitated antibiotic therapy during the last month
- •Malignancy (with the exception of in situ cancer) that has been declared treated within the last 5 years
- •Participant in another ongoing pharmacological study
- •Unwillingness to participate following oral and written information
- •If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- •Any concomitant disease or condition that may interfere with the possibility for the subject to comply with or complete the study protocol
- •Congestive heart failure (as suggested by anamnesis and by a value of NT-proBNP <155 ng/ml)
- •Subjects with any other severe acute or chronic medical or psychiatric condition that make the subject inappropriate for the study in the judgment of the Investigator
- •Known hypersensitivity to the active substance
- •Treatment with Prochlorperazine
- •History of asthma or chronic obstructive pulmonary disease
- •Renal insufficiency (cystatin clearance <60 ml/min)
- •Liver disease (ALAT/ASAT values >2 times the normal levels or INR > 1,2 or albumin levels < 36 g/ l or total bilirubin < 26 micromol/l or gamma GT <2 mikrokat/l)
- •Therapy with β-blockers
- •Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
- •Proliferative retinopathy
- •Sign for peripheric diabetic neuropathy (decreased/absent sensitivity to 10 g monofilament, vibration, plantar reflex)
结局指标
主要结局
Number of Endothelial Precursor Cells in 10 ml blood after intermittent hypoxia exposure
Number of Endothelial Precursor Cells in 10 ml blood after intermittent hypoxia exposure
次要结局
- Changes in the levels of angiogenetic chemokines (SDF-1, EPO, VEGF)
- Changes in the levels of angiogenetic and hypoxic induced genes (VEGFA, SDF-1, BPNP3, GLUT3, PDK1)
- Changes in electrophysiological parameters important for the cardiorespiratory response: R-R interval change, the standard deviation of the R-R interval, systolic and diastolic blood pressure, end-tidal carbon dioxide, arterial oxygen saturation, breathing rate, tidal volume, minute ventilation and the ratio between Vt and inspiration time (Vt/Ti), baroreflex sensitivity, arterial function parameters: pulse wave velocity, augmentation index, augmentation index corrected for heart rate (AI75)
研究者
Principal Investigator
Scientific
Karolinska University Hospital
研究点 (1)
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