MICRON: Comparing heart and kidney oxygen use in people with type 1 diabetes
Multifactorial Intervention to Reduce Cardiac and Renal Oxygen Need in Type 1 Diabetes (the MICRON Study) - A Steno 1 Substudy
This project tests whether a multifactorial treatment versus standard care changes heart and kidney oxygen use in people with long-standing type 1 diabetes who have kidney or cardiovascular risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 5 sites (Aarhus N and 4 other locations) |
| Trial ID | NCT07270172 on ClinicalTrials.gov |
What this trial studies
MICRON is an observational substudy recruiting participants from the larger Steno 1 trial to compare cardiac and renal oxygen consumption between those receiving a multifactorial intervention and those receiving standard care. Forty participants (20 on the multifactorial pathway and 20 on standard care) will undergo [11C]acetate PET/CT to measure myocardial and renal oxygen use, 99mTc-DTPA GFR measurement, and blood and urine biomarker sampling. Measurements occur at baseline, 6 months, and 24 months after enrolment in the parent trial using a long axial field-of-view PET scanner. No additional treatments are given as part of MICRON; the study links imaging and biomarker changes to the existing interventions in Steno 1.
Who should consider this trial
Good fit: Ideal candidates are people aged 40 or older with long-standing type 1 diabetes who are enrolled in the Steno 1 trial and have chronic kidney disease, prior cardiovascular disease, heart failure, high obesity, or elevated 5-year CVD risk.
Not a fit: People who are not enrolled in the Steno 1 trial, who lack the specified cardiorenal risk features, or who cannot undergo PET/CT or nuclear GFR testing are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could show that intensive multifactorial treatment reduces organ oxygen demand, suggesting lower cardiac and renal stress and potentially fewer long-term complications.
How similar studies have performed: While multifactorial interventions have improved outcomes in other diabetes studies, using [11C]acetate PET/CT to measure myocardial and renal oxygen consumption longitudinally is relatively novel and has limited prior large-sample evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus N and 4 other locations
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Regionshospitalet Gødstrup — Gødstrup, Denmark (Recruiting)
- Regionshospitalet Horsens — Horsens, Denmark (Recruiting)
- Regionshospitalet Silkeborg — Silkeborg, Denmark (Recruiting)
- Regionshospitalet Vibrg — Viborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Jakob A Østergaard, MD, PhD — Steno Diabetes Centre Aarhus
- Study coordinator: Sofie H Wilken, MD, PhD student
- Email: shw@clin.au.dk
- Phone: 004523653656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.