NCT07270172Recruiting
The MICRON Study - A Steno 1 Substudy
Multifactorial Intervention to Reduce Cardiac and Renal Oxygen Need in Type 1 Diabetes (the MICRON Study) - A Steno 1 Substudy
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 27 Oct 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- University of Aarhus
- Diseases
- Chronic kidney disease, Type 1 diabetes
- NCT number
- NCT07270172
What you commit to
- Study type: Observational
- Planned participants: 40
- From 27 Oct 2025 to the primary completion date, Jul 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Steno 1 inclusion criteria:
- Male or female persons ≥40 years old with T1D (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies (in accordance with local guidelines), or confirmed, at the investigator's discretion by the available medical records) during \>10 years.
- Presence of chronic kidney disease (UACR \>30 mg/g or eGFR \< 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\>35 kg/m2) OR 5-year CVD risk \>10% according to Steno Type 1 Risk Engine.
- Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening.
- Ability to communicate with the investigator and understand informed consent.
- Given written informed consent.
- Steno 1 exclusion criteria:
- Type 2 Diabetes, Maturity-onset diabetes of the young (MODY), secondary diabetes.
- History of pancreatitis.
- Body mass index \< 18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
- Known or suspected abuse of alcohol or recreational drugs.
- Participant in another drug-intervention study.
- Chronic Kidney Disease stage 5.
- Additional exclusion criteria in the MICRON study:
- Active malignant disease
- Use of study drugs (SGLT inhibitors, GLP-1 RA, or finererone) at inclusion.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Regionshospitalet Gødstrup Coordinator of this site? Confirm its status | Gødstrup | Denmark | Recruiting |
| Regionshospitalet Horsens Coordinator of this site? Confirm its status | Horsens | Denmark | Recruiting |
| Regionshospitalet Silkeborg Coordinator of this site? Confirm its status | Silkeborg | Denmark | Recruiting |
| Regionshospitalet Vibrg Coordinator of this site? Confirm its status | Viborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.