Type 1 diabetes and Type 3c diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Participants received in random order 7 days of placebo or dapagliflozin.
The expected duration of participant participation is approx. 64 days.
Randomisation procedu
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose concentration at 600 minutes following insulin cessation or at the time of glycaemic rescue, whichever occurs first, measured by blood test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Endogenous glucose production 2. Peripheral glucose uptake 3. Glycerol rate of appearance Stable isotopes of glucose and glycerol will be infused from -120 to 600 minutes. From -120 to 0 minutes, blood samples will be taken to measure glucose and glycerol enrichment 4. Urinary glucose excretion Urine samples will be collected at 2 hour intervals for measurement of spot glucose and urinary ketones (acetoacetic acid and acetone) until 600 minutes 5. Non-esterified fatty acid production 6. Ketone body production NEFA, and 3-beta hydroxybutyrate will be taken at 20minute intervals until 180 minutes and then at 30minute intervals until 600 minutes | — |
Countries
United Kingdom
Outcome results
None listed