Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6814
Source ID: NCT03361098
Associated Drug: Dapagliflozin 10mg
Title: DECREASE: Dapagliflozin Plus Exenatide on Central REgulation of Appetite in diabeteS typE 2
Acronym: DECREASE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Obesity
Interventions: DRUG: Dapagliflozin 10mg|DRUG: Exenatide|OTHER: placebo exenatide|OTHER: placebo dapagliflozin
Outcome Measures: Primary: Differences in neuronal activity in the central reward and satiety circuits in response to food-related stimuli by BOLD fMRI signal, Differences in neuronal activity in the central reward and satiety circuits in response to food related stimuli by BOLD fMRI signal compared to baseline and 16 weeks of treatment between the exenatide + dapagliflozine, exenatide +placebo, dapagliflozin+placebo and double placebo arms., at baseline, after 10 days and after 16 weeks | Secondary: Differences in neuronal activity in the central reward and satiety circuits in response to food-related stimuli by BOLD fMRI signal, Differences in neuronal activity in the central reward and satiety circuits in response to food related stimuli by BOLD fMRI signal compared to baseline and 1.5 weeks of treatment and 1.5 and 16 weeks of treatment between the exenatide + dapagliflozine, exenatide +placebo, dapagliflozin+placebo and double placebo arms., at baseline, after 10 days and after 16 weeks|Feeding behaviour; ad libitum lunch buffet, Feeding behaviour, measured as quantitative (kcal) changes in food choice, during an ad libitum lunch buffet will be compared between the groups (at baseline and 1,5 week, baseline and 16 weeks and 1.5 and 16 weeks of treatment), at baseline, after 10 days and after 16 weeks|Feeding behaviour; ad libitum lunch buffet, Feeding behaviour, measured as qualitative (energy density as well as nutrient composition;carbohydrate/fat/protein) changes in food choice, during an ad libitum lunch buffet will be compared between the groups (at baseline and 1,5 week, baseline and 16 weeks and 1.5 and 16 weeks of treatment), at baseline, after 10 days and after 16 weeks|Self-reported hunger, Self-reported hunger, satiety and fullness and prospective food consumption will be rated on 100 mm visual analogue scales before and after the meal, at baseline, after 10 days and after 16 weeks|Difference in resting energy expenditure measured by indirect calorimetry measurements, Difference in resting energy expenditure measured by indirect calorimetry measurements between the groups (baseline and 16 weeks, baseline and 1.5 weeks and 1.5 and 16 weeks of treatment), at baseline, after 10 days and after 16 weeks|Change in bodyweight (kg) and body mass index (kg/m2), Change in bodyweight (kg) and body mass index (kg/m2) between the groups ( at baseline and 1,5 week, baseline and 16 weeks, 1.5 week and 16 weeks), at baseline, after 10 days and after 16 weeks|Difference in bodycomposition measured by bio electrical impedance analysis and waist and hip circumference measurements (cm), Difference in bodycomposition measured by bio electrical impedance analysis and waist and hip circumference measurements (cm) between the groups (0-1.5, 0-16, 1.5-16), at baseline, after 10 days and after 16 weeks|Difference in resting brain activity by fMRI resting state measurements, Difference in resting brain activity by fMRI resting state measurements between groups (0-1.5, 0-16, 1.5-16), at baseline, after 10 days and after 16 weeks|Effect on cardiovascular autonomic balance by cardiovascular reflex test with finger plethysmography (Nexfin), Effect on cardiovascular autonomic balance by cardiovascular reflex test with finger plethysmography (Nexfin) measuring bloodpressure, hartfrequency, ECG between the groups (0-16, 0-1.5, 1.5-16), at baseline, after 10 days and after 16 weeks|Arterial stiffness: Pulse Wave analysis, Arterial stiffness: Pulse Wave analysis will be assessed using the Sphygmocor system, a non-invasive system using applanation tonometry between the groups (0-16, 0-1.5, 1.5-16), at baseline, after 10 days and after 16 weeks|Renal measurements collecting 24 hour urine, Renal measurements collecting 24 hour urine; glucose excretion (0-1.5, 0-16, 1.5-16), creatinine clearance (0-1.5, 0-16, 1.5-16), tubular function; sodium excretion and urinary pH (0-1.5, 0-16, 1.5-16), renal damage markers albumin/creatinine ratio (0-1.5, 0-16, 1.5-16), at baseline, after 10 days and after 16 weeks|Laboratory parameters, Change in the plasma/serum biomarkers of metabolism, liver function, estimated renal function (eGFR), electrolytes, and haematocrit, at baseline, after 10 days and after 16 weeks | Other: Safety outcomes; Adverse events, Occurence of adverse events (as reported by the patient) starting at the informed consent untill 30 days after administration of the last dose of study medication, +/- 21 weeks|Safety outcome; vital signs, Vital signs: pulse rate, bloodpressure, body temperature, 16 weeks|Exploratory objective: Cerebral perfusion assessed by Arterial Spin Labeling, Cerebral perfusion assessed by Arterial Spin Labeling between groups (0-1.5,0-16, 1.5-16), 16 weeks|Exploratory objective: measurement of hormones, blood will be collected to have the opportunity to perform measurements of hormones such as leptin, cortisol, ghrelin., 16 weeks|Exploratory: Microbiome, Fecal samples will be collected to determine the (change) microbiome, Baseline and after 16 weeks
Sponsor/Collaborators: Sponsor: Amsterdam UMC, location VUmc | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 65
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-09-18
Completion Date: 2020-03-25
Results First Posted:
Last Update Posted: 2021-06-11
Locations: Amsterdam UMC, location VU Medical Center, Amsterdam, Noord-Holland, 1081 HV, Netherlands
URL: https://clinicaltrials.gov/show/NCT03361098