| Trial ID: | L4991 |
| Source ID: | NCT03227484
|
| Associated Drug: |
Empagliflozin 25mg
|
| Title: |
Effect of Empagliflozin Versus Placebo on Brain Insulin Sensitivity in Patients With Prediabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
PreDiabetes|Body Weight
|
| Interventions: |
DRUG: Empagliflozin 25mg|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: effect of treatment with 25 mg empagliflozin daily versus placebo on regional brain insulin sensitivity, assessed by functional magnetic resonance imaging (fMRI) combined with nasal insulin administration as change from baseline to 8 weeks, baseline and after 8 weeks of treatment | Secondary: effects of treatment with empagliflozin versus placebo on glucose tolerance in prediabetes, assessed by 75g oral glucose tolerance test (oGTT) as change from baseline to 8 weeks, baseline and after 8 weeks of treatment|effects of treatment with empagliflozin versus placebo on body fat composition, assessed by whole body MRI and liver MR-spectroscopy and bioimpedance analysis as change from baseline to 8 weeks, baseline and after 8 weeks of treatment|effect of treatment with empagliflozin versus placebo on brain-insulin derived modulation of peripheral metabolism, assessed by hyperinsulinemic euglycemic clamp combined with nasal insulin administration as change from baseline to 8 weeks, baseline and after 8 weeks of treatment|effect of treatment with empagliflozin versus placebo on autonomous nervous system activity, assessed by analysis of heart rate variability as change from baseline to 8 weeks, baseline and after 8 weeks of treatment|effect of treatment with empagliflozin versus placebo on the brain responsiveness to food cues and nutrient-specific food preference, assessed by fMRI combined with nasal insulin administration as change from baseline to 8 weeks, baseline and after 8 weeks of treatment|effect of treatment with empagliflozin versus placebo on the correlation between insulin secretion capacity and regional brain insulin sensitivity, assessed by fMRI combined with nasal insulin administration and 75g oGTT as change from baseline to 8 weeks, baseline and after 8 weeks of treatment|effect of treatment with empagliflozin versus placebo on energy expenditure, assessed by indirect calorimetry as change from baseline to 8 weeks, baseline and after 8 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Tuebingen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2017-06-09
|
| Completion Date: |
2019-11-18
|
| Results First Posted: |
|
| Last Update Posted: |
2020-04-29
|
| Locations: |
University of Tuebingen, Department of Internal Medicine IV, Tübingen, 72076, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03227484
|
