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Clinical Trial Details

Trial ID: L3796
Source ID: NCT02798744
Associated Drug: Empagliflozin
Title: SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation.
Acronym: SEESAW
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Empagliflozin|BEHAVIORAL: Diet|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in Total PYY at 24 weeks, The effect of Empagliflozin on appetite hormone 'Total PYY' concentration between baseline and 24 weeks. Measured by sequential blood sampling at study visits 1-5., Baseline and 24 weeks | Secondary: Change from baseline in Ghrelin at 24 weeks, Change in appetite hormone 'Ghrelin' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5., Baseline and 24 weeks|Change from baseline in GLP-1 to 24 weeks, Change in appetite hormone 'GLP-1' concentration from baseline to 24 weeks. Measured by blood sampling at study visits 1-5., Baseline and 24 weeks|Change from baseline in appetite perceptions to 24 weeks, Change in appetite perceptions from baseline to 24 weeks. Measured by questionnaires visits 1 -5., Baseline and 24 weeks|Change in Weight (kg) from baseline to 24 weeks, Change in weight (kg) from baseline to study end and between groups. This will be measured at visits 1 - 5., Baseline and 24 weeks|Change in Body composition from baseline to 24 weeks, Change in body composition from baseline to study end and between groups. This will be measured by Dual Energy X-Ray Absorptiometry (DEXA) scanning at visits 1 and 5., Baseline and 24 weeks|Change in resting energy expenditure from baseline to 24 weeks, Change in resting energy expenditure from baseline to study end and between groups. This will be measured by indirect calorimetry at visits 1-5., Baseline and 24 weeks|Change in objectively measured Physical Activity from baseline to 24 weeks using activity monitors, Change in physical activity from baseline to study end and between groups. This will be measured using physical activity monitors at visits 0, 3, 4 and 5., Baseline and 24 weeks|Change in subjectively measured Physical Activity from baseline to 24 weeks using the International Physical Activity Questionnaire (IPAQ), Change in physical activity from baseline to study end and between groups. This will be measured using the international physical activity questionnaire at visits 1 - 5., Baseline and 24 weeks|Change from baseline urine glucose excretion to 24 weeks., Change in urine glucose excretion to study end and between groups. This will be measured using urine sampling at visits 1-5., Baseline and 24 weeks|Change from baseline in blood appetite hormones to 24 weeks, Change in in baseline blood appetite hormones to 24 weeks between groups. This will be measured using blood sampling at visits 1-5., Baseline and 24 weeks|Change from baseline in HbA1c to 24 weeks, Change in in baseline HbA1c to 24 weeks between groups. This will be measured using blood sampling at visits 1-5., Baseline and 24 weeks|Change from baseline in inflammatory markers to 24 weeks, Change in in baseline inflammatory markers to 24 weeks between groups. This will be measured using blood sampling at visits 1-5., Baseline and 24 weeks|Change from baseline in renal functioning to 24 weeks, Change in in baseline renal functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5., Baseline and 24 weeks|Change from baseline in liver functioning to 24 weeks, Change in in baseline liver functioning to 24 weeks between groups. This will be measured using blood sampling at visits 1-5., Baseline and 24 weeks
Sponsor/Collaborators: Sponsor: University of Leicester | Collaborators: Loughborough University|University Hospitals, Leicester
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 68
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-12
Completion Date: 2019-07-30
Results First Posted:
Last Update Posted: 2020-01-30
Locations: Leicester Diabetes Centre, Leicester, LE5 4PW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02798744