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Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe (DiaKidZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589351
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : January 18, 2022
Sponsor:
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
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetic Kidney Disease Drug: Ezetimibe 10mg Drug: Placebo Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study consists of a cross-sectional study and an intervention trial. The latter is a single-center, randomized, double-blinded, placebo-controlled and parallel trial in participants with T2D and non-severe diabetic kidney disease.

Trial participants (n=60), by virtue of their baseline examinations (e.g. MR-examinations), also participate in the cross-sectional part of this study where they constitute one of three groups. The other two groups contain controls (n=30) and individuals with T2D and no diabetic kidney disease (n=30).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: To ensure blinding to the trial drug, the tablets containing either ezetimibe or placebo are incapsulated with gelatin and thus identical in appearance (size, color and shape).
Primary Purpose: Treatment
Official Title: Kidney Fat in Type 2 Diabetes & Diabetic Kidney Disease and the Effects of Ezetimibe: A Cross-Sectional Study and Randomized, Placebo-Controlled Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ezetimibe
One treatment period of 16 weeks with1 capsule of ezetimibe 10mg per day, as add-on to standard care.
 Drug: Ezetimibe 10mg
Ezetimibe is a cholesterol absorption inhibitor with marketing approval. The recommended dose as per label is 10mg once a day.
Placebo Comparator: Placebo
One treatment period of 16 weeks with 1 capsule of matching placebo per day, as add-on to standard care.
 Drug: Placebo
Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Urinary albumin creatinine ratio (UACR) [ Time Frame: Change over 16 weeks of treatment ]

Secondary Outcome Measures :
  1. Magnetic resonans estimate of kidney parenchymal triglyceride fraction [ Time Frame: Change over 16 weeks of treatment ]

Other Outcome Measures:
  1. Urine metabolomic profile [ Time Frame: Change over 16 weeks of treatment ]
    Metabolomic profiling of polar and non-polar urinary metabolites

  2. Plasma extracellular vesicles [ Time Frame: Change over 16 weeks of treatment ]
    number, number from relevant cell types and for all extracellular vesicles the presence of fatty acid transporter proteins

  3. Urine extracellular vesicles [ Time Frame: Change over 16 weeks of treatment ]
    number, number from relevant cell types and for all extracellular vesicles the presence of fatty acid transporter proteins


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for the intervention trial

  • Age ≥ 40 and ≤ 75 years
  • T2D (World Health Organization criteria)
  • eGFR ≥ 30ml/min/1,73m2 at screening
  • Persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months)
  • LDL > 1.5mmol/L at screening
  • Ability to communicate with the investigator and give informed consent

Exclusion criteria for the intervention trial

  • Chronic kidney disease primarily ascribed to other causes than diabetes
  • Acute kidney disease within 3 months
  • No UACR ≥ 3000mg/g in history
  • Current or recent (within 3 months) treatment with ezetimibe
  • Initiation or adjustment in dosage within 1 month of an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), glucagon-like peptide-1 receptor (GLP-1RA) agonists, sodium-glucose cotransporter 2 (SGLT-2) inhibitors or anti-dyslipidemia drug, e.g. a statin
  • Any contraindication to MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination, claustrophobia or body size not compatible with the scanner)
  • Intolerance to trial drug components
  • Any previous major organ transplantation
  • Elective major surgery during the trial
  • Pregnancy, planned pregnancy or breastfeeding during the trial
  • Insufficient contraception during the trial in women of childbearing potential
  • Severe alcohol consumption or abuse of recreational drugs
  • Moderate to severe liver failure (Child Pugh 7-15)
  • Any surgical or medical condition which can be expected to significantly alter the absorption of the trial drug (e.g. major gastrointestinal tract surgery or inflammatory bowel disease)
  • Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
  • Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the trial
  • Any reason for suspecting a considerable lack of compliance to the trial

Inclusion criteria for the control group (cross-sectional study alone):

  • Age ≥ 40 and ≤ 75 years
  • eGFR ≥60ml/min/1,73m2 at screening
  • Ability to communicate with the investigator and give informed consent

Exclusion criteria for the control group (cross-sectional study alone):

  • Any major chronic disease, e.g. diabetes mellitus, chronic kidney disease, ischemic heart disease, chronic obstructive pulmonary disease (this criterium does not include conditions that may be considered risk factors for chronic diseases, e.g. essential hypertension, primary hypercholesterolemia)
  • Acute kidney disease within 3 months
  • History of persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months including those at screening) or a previous diagnosis of micro- or macroalbuminuria
  • Current or recent (within 3 months) treatment with ezetimibe
  • Any contraindication to an MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination or claustrophobia)
  • Any previous major organ transplantation
  • Elective major surgery during the study
  • Pregnancy, planned pregnancy or breastfeeding during the study
  • Severe alcohol consumption or abuse of recreational drugs
  • Moderate to severe liver failure (Child Pugh 7-15)
  • Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
  • Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the study
  • Any reason for suspecting a considerable lack of compliance to the study

Inclusion criteria for the group of participants with T2D and no DKD (cross-sectional study alone):

  • Age ≥ 40 and ≤ 75 years
  • T2D (World Health Organization criteria)
  • eGFR ≥60ml/min/1,73m2 at screening
  • Ability to communicate with the Investigator and give informed consent

Exclusion criteria for the group of participants with T2D and no DKD (cross-sectional study alone):

  • Any chronic kidney disease
  • Acute kidney disease within 3 months
  • History of persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months including those at screening) or a previous diagnosis of micro- or macroalbuminuria
  • Current or recent (within 3 months) treatment with ezetimibe
  • Any contraindication to an MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination or claustrophobia)
  • Any previous major organ transplantation
  • Elective major surgery during the study
  • Pregnancy, planned pregnancy or breastfeeding during the study
  • Severe alcohol consumption or abuse of recreational drugs
  • Moderate to severe liver failure (Child Pugh 7-15)
  • Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
  • Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the study procedures
  • Any reason for suspecting a considerable lack of compliance to the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589351


Locations
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Denmark
Steno Diabetes Center Copenhagen
Gentofte, Capital Region, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
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
More Information
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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04589351    
Other Study ID Numbers: 16032020
2020-001155-40 ( EudraCT Number )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
 Diabetes Complications
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents