The MICRON Study - A Steno 1 Substudy

Summary

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.

Eligibility

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.

Conditions3

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