The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).
Different medical therapies and lifestyle modification for the prevention of type 2 diabetes have yet to be compared head-to-head in individuals with pre-diabetes. This research project will compare different glucose-lowering interventions in overweight and obese individuals with HbA1c levels in the pre-diabetic range.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
10 mg per day as monotherapy for 13 weeks
2 x 850 mg per day as monotherapy for 13 weeks
Interval training, 5 times per week, 30 min per session
Steno Diabetes Center A/S
Gentofte Municipality, Denmark
Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring
Time frame: Change from baseline to 13 weeks and 26 weeks
Intra-day glycaemic variability as assessed by continuous overall net glycaemic action (CONGA)
Time frame: Change from baseline to 13 weeks and 26 weeks
Daily time spent above different glucose concentrations ( e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)
Time frame: Change from baseline to 13 weeks and 26 weeks
HbA1c
Time frame: Change from baseline to 13 weeks and 26 weeks
Glucose concentrations during OGTT
Time frame: Change from baseline to 13 weeks and 26 weeks
Insulin secretion as assessed by the insulinogenic index
Time frame: Change from baseline to 13 weeks and 26 weeks
Insulin sensitivity as assessed by the insulin sensitivity index
Time frame: Change from baseline to 13 weeks and 26 weeks
Body weight (kg)
Time frame: Change from baseline to 13 weeks and 26 weeks
Body fat (%) as assessed by DEXA scan
Time frame: Change from baseline to 13 weeks and 26 weeks
Cardiorespiratory fitness as assessed by maximal oxygen uptake (VO2 max)
Time frame: Change from baseline to 13 weeks and 26 weeks
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Respiratory exchange ratio (RER) as assessed by indirect calorimetry
Time frame: Change from baseline to 13 weeks and 26 weeks
Basal metabolic rate (BMR) as assessed by indirect calorimetry
Time frame: Change from baseline to 13 weeks and 26 weeks
Time spent sedentary and in moderate-to-vigorous physical activity intensity as assessed by accelerometer
Time frame: Change from baseline to 13 weeks and 26 weeks
Systolic and diastolic blood pressure
Time frame: Change from baseline to 13 weeks and 26 weeks
Plasma lipids
Time frame: Change from baseline to 13 weeks and 26 weeks
Number of self-reported adverse events and side effects
Time frame: Change from baseline to 13 weeks and 26 weeks
Self-rated health and quality of life as assessed by questionnaire
Time frame: Change from baseline to 13 weeks and 26 weeks
Sleep habits as assessed by questionnaire
Time frame: Change from baseline to 13 weeks and 26 weeks
Dietary intake as assessed by a food diary
Time frame: Change from baseline to 13 weeks and 26 weeks
Adherence to the different interventions as assessed by number of tablets returned or number of training passes completed
Time frame: Change from baseline to 13 weeks and 26 weeks
Responsiveness to interventions in individuals with different glucose tolerance status (impaired fasting glycaemia vs. impaired glucose tolerance)
Time frame: Change from baseline to 13 weeks and 26 weeks