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Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe

NCT04589351 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-18

No results posted yet for this study

Summary

In this study, we seek to explore the importance of fat accumulation in the kidneys in relation to diabetic kidney disease (DKD). To do this, we conduct an intervention trial in individuals with type 2 diabetes (T2D) and DKD where we investigate whether the inhibition of intestinal cholesterol absorption with ezetimibe affects albuminuria (a strong risk factor for diabetic complications) and kidney fat accumulation. At the same time and to confirm that kidney fat accumulation is, in fact, abnormal in T2D and DKD, we conduct a cross-sectional study in which we compare kidney fat accumulation in participants at baseline from the intervention trial with a group of individuals with T2D and no DKD and a group of healthy individuals.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetic Kidney Disease

Interventions

DRUG

Ezetimibe 10mg

Ezetimibe is a cholesterol absorption inhibitor with marketing approval. The recommended dose as per label is 10mg once a day.

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Department of Clinical Physiology, Nuclear Medicine and PET at Rigshospitalet Glostrup, Valdemar Hansens Vej 1-23, 2600 Glostrup, Denmark

    collaborator UNKNOWN

  • Aalborg University Hospital

    collaborator OTHER

  • Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark

    collaborator UNKNOWN

  • Alessia Fornoni, MD PhD, Professor of Medicine, Chief, Katz Family Division of Nephrology and Hypertension

    collaborator UNKNOWN

  • Steno Diabetes Center Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589351 on ClinicalTrials.gov