This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.
The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Novo Nordisk Investigational Site
Guildford, United Kingdom
Total Energy Expenditure, Double-labelled Water Method
Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.
Time frame: Weeks 14-16, weeks 30-32
Total Energy Expenditure, Dietary Record Method
The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.
Time frame: Weeks 14-16, weeks 30-32
Component of Total Energy Expenditure: Resting Energy Expenditure (REE)
Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation.
Time frame: Week 14, week 30
Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)
Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake.
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Time frame: Week 14, week 30
Component of Total Energy Expenditure: Physical Activity Thermogenesis
Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32).
Time frame: Week 16, week 32
Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)
Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT.
Time frame: Week 16, week 32
Body Weight
Body weight after each treatment period.
Time frame: Week 16, week 32
Lean Body Mass
Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.
Time frame: Week 16, week 32
Fat Mass
Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.
Time frame: Week 16, week 32
Waist:Hip Ratio
At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100.
Time frame: Week 16, week 32
Hormonal Assessment: Adiponectin
Adiponectin levels after each treatment period.
Time frame: Week 14, week 30
Hormonal Assessment: Insulin-like Growth Factor-1
Insulin-like growth factor-1 (IGF-1) levels after each treatment period.
Time frame: Week 14, week 30
Hormonal Assessment: Resistin
Resistin levels after each treatment period.
Time frame: Week 14, week 30
Hormonal Assessment: Leptin
Leptin levels after each treatment period.
Time frame: Week 14, week 30
Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated haemoglobin A1c (HbA1c) after each treatment period.
Time frame: Week 16, week 32
Fasting Plasma Glucose
Fasting plasma glucose (FPG) after each treatment period.
Time frame: Week 16, week 32
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in the study.
Time frame: Weeks 0-32
Hypoglycaemic Episodes, Diurnal/Nocturnal
Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.
Time frame: Weeks 0-32