Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04589351
Status:
UNKNOWN
Last Update Posted:
2022-01-18
First Post:
2020-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiaKidZ
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.
Detailed Description:
Objective:
1. To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease.
2. To assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.
Design:
1. Cross-sectional study on 30 controls, 30 individuals with type 2 diabetes and no diabetic kidney disease and 60 individuals with type 2 diabetes and non-severe diabetic kidney disease.
2. Single-center, randomized, double-blinded, placebo-controlled and parallel intervention trial in 60 individuals with type 2 diabetes and non-severe diabetic kidney disease Comparative treatment regime: Ezetimibe 10mg per day versus placebo for 16 weeks
Primary endpoint in cross-sectional study:
* Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)
Primary endpoint in intervention trial:
* Urinary albumin creatinine ratio
Secondary endpoint in intervention trial:
• Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)
Main eligibility criteria for control group (cross-sectional study alone):
• Age 40-75 years
• No diabetes mellitus
• No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
• No contraindication to examination by magnetic resonance
Main eligibility criteria for group of individuals with type 2 diabetes and no diabetic kidney disease (cross-sectional study alone):
• Age 40-75 years
* Type 2 diabetes
* No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
* No contraindication to examination by magnetic resonance
Main eligibility criteria for group of individuals with type 2 diabetes and non-severe diabetic kidney disease (intervention trial):
• Age 40-75 years
* Type 2 diabetes
* Estimated glomerular filtration rate ≥30ml/min/1,73m2
* Urinary albumin creatinine ratio ≥ 30mg/g
* No contraindication to examination by magnetic resonance
Recruitment
* Controls are recruited via announcements on relevant websites and, if necessary, in newspapers
* Individuals with type 2 diabetes are primarily recruited from the ambulatory at Steno Diabetes Center Copenhagen
1. To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease.
2. To assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.
Design:
1. Cross-sectional study on 30 controls, 30 individuals with type 2 diabetes and no diabetic kidney disease and 60 individuals with type 2 diabetes and non-severe diabetic kidney disease.
2. Single-center, randomized, double-blinded, placebo-controlled and parallel intervention trial in 60 individuals with type 2 diabetes and non-severe diabetic kidney disease Comparative treatment regime: Ezetimibe 10mg per day versus placebo for 16 weeks
Primary endpoint in cross-sectional study:
* Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)
Primary endpoint in intervention trial:
* Urinary albumin creatinine ratio
Secondary endpoint in intervention trial:
• Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)
Main eligibility criteria for control group (cross-sectional study alone):
• Age 40-75 years
• No diabetes mellitus
• No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
• No contraindication to examination by magnetic resonance
Main eligibility criteria for group of individuals with type 2 diabetes and no diabetic kidney disease (cross-sectional study alone):
• Age 40-75 years
* Type 2 diabetes
* No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
* No contraindication to examination by magnetic resonance
Main eligibility criteria for group of individuals with type 2 diabetes and non-severe diabetic kidney disease (intervention trial):
• Age 40-75 years
* Type 2 diabetes
* Estimated glomerular filtration rate ≥30ml/min/1,73m2
* Urinary albumin creatinine ratio ≥ 30mg/g
* No contraindication to examination by magnetic resonance
Recruitment
* Controls are recruited via announcements on relevant websites and, if necessary, in newspapers
* Individuals with type 2 diabetes are primarily recruited from the ambulatory at Steno Diabetes Center Copenhagen
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-001155-40 | EUDRACT_NUMBER | None | View |