ISRCTN16404006已完成4 期
Metabolic effects of an SGLT2 inhibitor (dapagliflozin) during a period of acute insulin withdrawal and development of ketoacidosis in people with type 1 diabetes
niversity of Leicester0 个研究点目标入组 12 人开始时间: 2020年1月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
2020 results in https://doi.org/10.2337/dc19-2579 (added 07/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities
- •2. Type 1 diabetes or type 3c (chronic pancreatitis or undergone pancreatic surgery) according to clinical judgment
- •3. Duration of type 1 or type 3c diabetes (chronic pancreatitis or undergone pancreatic surgery) greater than 12 months
- •4. Current treatment basal bolus insulin regime or insulin pump therapy
- •5. Aged 18 – 65 years
- •6. BMI of less than 35
- •7. HbA1c of greater or equal to 6.5% and less than 9%
- •8. Able and willing to complete the study
- •9. Patients who are or who have previously been involved in research are eligible provided they have not received an investigational drug within one month of entry into the study
排除标准
- •1. Cannot adequately understand verbal and / or written explanations given in English
- •2. LADA –latent autoimmune diabetes in adults due to differing nature of the illness/Type 1
- •3. Confirmed excessive and compulsive drinking of alcohol i.e. alcohol abuse as determined from GP medical notes by the Fast Alcohol Screening Test (FAST) or history of previous alcohol abuse
- •4. Restricted food intake (e.g. on VLC diets) - as this depletes the person of calories and may affect your data. Consider excluding Individuals on a severe calorie restricted diet <800cals/day. Determined by history
- •5. Diagnosis of osteoporosis confirmed by DEXA scan
- •6. Proliferative retinopathy that has required acute treatment within last three months
- •7. Moderate to severe renal impairment (creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m²
- •8. History of unstable or rapidly progressing renal disease
- •9. Severe hepatic insufficiency / and or significant abnormal liver function defines as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) > 3ULN
- •10. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
- •11. Congestive heart failure defined as New York Heart Association (NYHA) class III and IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially:
- •11.1. Uncontrolled cardiac arrhythmias
- •11.2. Uncontrolled hypertension (BP greater than 160/90)
- •12. Mental incapacity
- •13. Pregnancy or breastfeeding women
- •14. Those of child-bearing potential not taking adequate contraception precautions. Adequate protection is defined as barrier protection, oral contraceptive pill or intrauterine device
- •15. Volume depleted patients, patients at risk of volume depleting due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
- •16. History of unstable angina.
- •17. Recent Cardiovascular Events in a patient:
- •17.1. Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
- •17.2. Hospitalisation for unstable angina or acute myocardial infarction within 2 months prior to enrolment
- •17.3. Acute Stroke or TIA within 2 months prior to enrolment
- •17.4. Less than 2 months post coronary artery revascularization
- •17.5. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. Accident and Emergency and/or hospitalisation) within 1 month prior to the Screening visit
- •18. Known or suspected allergy to study products
- •19. Known lactose-intolerant
- •20. Any other medical or psychological conditions that would interfere with the study participation
研究者
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