DRKS00027136招募中未知
Glycaemic, cardiac and hormonal response to metabolic matched cycling and running exercise in individuals with type 1 diabetes: a randomized crossover trial - CYCRUN-1
Division Exercise Physiology and Metabolism0 个研究点目标入组 20 人开始时间: 2021年11月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Adults with type 1 diabetes mellitus (as diagnosed clinically) = 12 months
- •-Treated with multiple daily injections = 12 months
- •-Body mass index 18.0-29.4 kg/m2 (both inclusive)
- •-Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min
- •-HbA1c = 10% (86 mmol/mol)
- •-Using a CGM/isCGM
排除标准
- •-Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the past 12 months)
- •-Impaired awareness of hypoglycaemia as judged by the Investigator based on Gold Score (=4)
- •-Hospitalisation for diabetic ketoacidosis during the previous 12 months.
- •-Enrolment in other study
- •-Known or suspected hypersensitivity to trial product(s) or related products
- •-Receipt of any investigational medicinal product within 1 week prior to screening in this trial
- •-Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism and cardiopulmonary systems (e.g. insulin, oral antidiabetic medication, lipid lowering medication, medication referring heart failure) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial.
- •-Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •-Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives
- •-Significant abnormal ECG at screening, as judged by the Investigator
- •-Any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator might jeopardise participant’s safety or compliance with the protocol
- •-History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •-Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial
- •-Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator
- •-Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner).
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