| Trial ID: | L7288 |
| Source ID: | NCT04589351
|
| Associated Drug: |
Ezetimibe 10mg
|
| Title: |
Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe
|
| Acronym: |
DiaKidZ
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Diabetic Kidney Disease
|
| Interventions: |
DRUG: Ezetimibe 10mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Urinary albumin creatinine ratio (UACR), Change over 16 weeks of treatment | Secondary: Magnetic resonans estimate of kidney parenchymal triglyceride fraction, Change over 16 weeks of treatment | Other: Urine metabolomic profile, Metabolomic profiling of polar and non-polar urinary metabolites, Change over 16 weeks of treatment|Plasma extracellular vesicles, number, number from relevant cell types and for all extracellular vesicles the presence of fatty acid transporter proteins, Change over 16 weeks of treatment|Urine extracellular vesicles, number, number from relevant cell types and for all extracellular vesicles the presence of fatty acid transporter proteins, Change over 16 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Department of Clinical Physiology, Nuclear Medicine and PET at Rigshospitalet Glostrup, Valdemar Hansens Vej 1-23, 2600 Glostrup, Denmark|Aase Handberg, professor, dr.med., Department of Clinical Biochemistry, Aalborg University Hospital|Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark|Alessia Fornoni, MD PhD, Professor of Medicine, Chief, Katz Family Division of Nephrology and Hypertension
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-10-01
|
| Completion Date: |
2022-05
|
| Results First Posted: |
|
| Last Update Posted: |
2022-01-18
|
| Locations: |
Steno Diabetes Center Copenhagen, Gentofte, Capital Region, 2820, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT04589351
|
