Actively Recruiting
The MICRON Study - A Steno 1 Substudy
Led by University of Aarhus · Updated on 2026-02-02
40
Participants Needed
5
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to compare cardiac and renal oxygen consumption among subjects with type 1 diabetes treated with either multifactorial intervention or according to the current standard care. Participants are recruited from a main study /the Steno1 study) responsible for the intervention. The main questions it aims to answer are if a multifactorial intervention in subjects with type 1 diabetes targeting cardiovascular and renal risk factors, will reduce cardiac and renal oxygen demand. Participants will undergo the following examinations at 0-month, 6-month, and 24-month after enrolling in the main study: * Measurement of cardiac and real oxygen consumption (\[11C\]acetate PET/CT-scan) * Measurement of kidney function (\[99mTc\]DTPA GFR measurement) * Measurement of markers of heart and kidney disease in blood and urine samples.
CONDITIONS
Official Title
The MICRON Study - A Steno 1 Substudy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female persons 40 years old or older with type 1 diabetes diagnosed before age 30 with insulin from onset, or if diagnosed after 30 years, insulin from onset with diabetic ketoacidosis or positive autoantibodies
- Duration of diabetes over 10 years
- Presence of chronic kidney disease (urine albumin-creatinine ratio >30 mg/g or estimated glomerular filtration rate <60 ml/min/1.73 m2) OR history of ischemic heart disease (myocardial infarction, stroke, or angina) OR history of heart failure OR obesity grade 2 or 3 (BMI >35 kg/m2) OR 5-year cardiovascular disease risk >10% according to Steno Type 1 Risk Engine
- Fertile females must use highly effective contraception methods during the study and for at least 2 months after stopping study drug, or be in menopause, surgically sterilized, or hysterectomized for at least 12 months prior to screening
- Ability to communicate with the investigator and understand informed consent
- Given written informed consent
You will not qualify if you...
- Type 2 diabetes, maturity-onset diabetes of the young, or secondary diabetes
- History of pancreatitis
- Body mass index less than 18.5 kg/m2
- Females of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or are not using adequate contraception
- Known or suspected abuse of alcohol or recreational drugs
- Participation in another drug intervention study
- Chronic kidney disease stage 5
- Active malignant disease
- Use of study drugs (SGLT inhibitors, GLP-1 receptor agonists, or finerenone) at inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
2
Regionshospitalet Gødstrup
Gødstrup, Denmark, 7400
Actively Recruiting
3
Regionshospitalet Horsens
Horsens, Denmark, 8700
Actively Recruiting
4
Regionshospitalet Silkeborg
Silkeborg, Denmark, 8600
Actively Recruiting
5
Regionshospitalet Vibrg
Viborg, Denmark, 8800
Actively Recruiting
Research Team
S
Sofie H Wilken, MD, PhD student
CONTACT
J
Jakob A Østergaard, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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