MICRON: Comparing heart and kidney oxygen use in people with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.