DRKS00013509已完成未知
Influence of adjusting rapid-acting insulin aspart on post-exercise nocturnal hypoglycaemia in recreationally active people with type 1 diabetes on insulin degludec - HypEx
Abertawe Bro Morgannwg Unviersitz Local Health Board, 1St Floor, Institute of Life Science0 个研究点目标入组 19 人开始时间: 2019年1月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 19
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 65 Years（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Male or female aged 18-65 years (both inclusive).
- •Type 1 diabetes mellitus (as diagnosed clinically) = 12 months.
- •Treated with multiple daily insulin injections = 12 months
- •Body mass index 18.0-29.4 kg/m2 (both inclusive).
- •If patients’ BMI is above 29.4 kg/m2 due to muscular hypertrophy, the bioelectrical impendence analysis (BIA) will be used as a further assessment criterion. If patients’ fat-free mass (%) is within ±5% of normal reference values the investigators can include the patient.
- •Mass-specific VO2peak >20 mlO2/kg body weight/min.
- •Participants performing regular physical cardiorespiratory activity (physically active for at least 30 min at a time, three times per week) (short International Physical Activity Questionnaire (IPAQ) assessed).
- •HbA1c = 9.5 %
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Receipt of any investigational medicinal product within 3 months prior to screening in this trial
- •Known haemoglobin <8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L, serum creatinine levels = 126 µmol/L (male) or = 111 µmol/L (female), alanine aminotransferase > 2 x the upper limit of normal (ULN), bilirubin > 3 x ULN, alkaline phosphatase > 2 x ULN
- •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 any clinically significant disease that might influence the participation or the study results, as judged by the Investigator
- •Participant with a heart rate < 40 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
- •Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 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 antihypertensives
- •Clinically significant abnormal ECG at screening, as judged by the Investigator
- •Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- •Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardize participant’s safety or compliance with the protocol
- •Participant known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis), for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction (except celiac disease – patient must exclude foods that contain gluten from the diet)
- •Participant who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening.
- •Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
- •Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective or selective beta-blockers, growth hormone. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months
- •Significant history of alcoholism or drug/chemical abuse as per Investigator’s judgement.
- •Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking, or use of nicotine substitute products during the inpatient period
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months).
- •Hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general pra
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