None listed
Conditions
Brief summary
When people with Diabetes exercise it can make their blood sugar drop too low, for this doctors recommend ways to adjust insulin before exercising. SGLT Inhibitors can increase the risk of Diabetic Ketoacidosis. The Abbott Sensor-Based Ketone Monitoring system will be used to assess the effect ketone responses during exercise in people with type 1 diabetes. We believe that ketones will risk in individuals that undertake high intensity interval exercise.
Interventions
After screening, participants will undergo a 2-week run-in period where they will wear a continuous glucose monitor and ketone sensor and receive education about management of sustained hyperglycemia/ketosis.
After run-in, participants will be randomized to either the intervention or placebo.
The intervention will be Dapagliflozin 200 mg oral tablet daily for three months.
Adherence to intervention will be monitored by counting number of study drugs returned at the end of intervention.
1 exercis
After screening, participants will undergo a 2-week run-in period where they will wear a continuous glucose monitor and ketone sensor and receive education about management of sustained hyperglycemia/ketosis. After run-in, participants will be randomized to either the intervention or placebo. The intervention will be Dapagliflozin 200 mg oral tablet daily for three months. Adherence to intervention will be monitored by counting number of study drugs returned at the end of intervention. 1 exercise session of 40 minutes will be completed after 6-weeks of each arm, a total of two sessions one during the 12-week dapagliflozin and one during the placebo treatment period. The sessions will be conducted between 07:00 and 09:30 in the morning proceeding an overnight fast from the previous evening. The exercise session will be high intensity (80-90% of age predicted max heart rate) interval cardio session on a cycle ergometer. The session will entail 4 x 5min 'hard' intervals ensuring the participant is working between the prescribed heart rate limits. The participant will wear a heart rate monitor to ensure appropriate intensity and these sessions will be supervised by post-doctoral research fellows who have experience conducting clinical research exercise sessions. Wash-out period is 2 weeks between interventions. Arm 1: Dapagliflozin for 12 weeks, exercise session post week 6 of intervention. Then cross-over to Placebo for 12 weeks after washout Arm 2: Placebo for 12 weeks, exercise session post week 6 of intervention. Then cross-over to dapagliflozin for 12 weeks after washout Session attendance will be recorded in our database and monitored by investigators to ensure adherence to exercise session requirements within the required timeframes.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age equal to or greater than 18 years; type 1 diabetes of more than 1 year duration; stable on insulin therapy; HbA1c <10.0%; access to a mobile phone compatible with the ketone monitoring system; willing to adhere to all requirements of the protocol including wearing and responding to information provided by the continuous ketone sensor for the duration of the study.
Exclusion criteria
Pregnancy or planned pregnancy; eGFR<30 ml/minute/1.73m2; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; use of low carbohydrate diet; heavy alcohol use; major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.
Outcome results
None listed