MICRON

Recruiting

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

Lead sponsor

University of Aarhus

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 1 diabetes

Key I/E criteria

•BMI ≥35•eGFR ≤60•UACR ≥30

Primary endpoints

•Myocardial oxygen consumption•Renal oxygen consumption

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07270172

Org study IDMICRON

Timeline

Milestones

Study start2025-10-27actual

Study first posted2025-12-08actual

Last update posted2026-02-02actual

Primary completion2028-07estimated (month precision)

Study completion2028-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

The study population for the Steno1 Study is persons with Type 1 Diabetes at the Steno Diabetes Centre and at partner clinics in Region Midt, Denmark. The MICRON study will recruit from these participants.

Eligibility 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.

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney

Other (unclassified)

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

MASH / liver

Heart failure

Glycemic / diabetes

2 endpoints

Other/protocol endpoint

Plasma glucose

Time frame:Will be measured regularly (at least hourly) at the three study visits (baseline, 6 months, and 24 months) to monitor levels during fasting.

descriptive

Other/protocol endpoint

Hemoglobin A1c

Time frame:At baseline (0 month), at 6 months and 24 months.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint

Other/protocol endpoint

Liver enzymes

Time frame:At baseline (0 month), at 6 months and 24 months.

change from baseline, improvement

Heart failure

1 endpoint

Other/protocol endpoint

Pro-brain natriuretic peptide

Time frame:At baseline (0 month), at 6 months and 24 months.

NT-proBNP, change

change from baseline, improvement

Renal / kidney

6 endpoints

Primary/protocol endpoint

Renal oxygen consumption

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Secondary/protocol endpoint

Renal perfusion

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Secondary/protocol endpoint

Amount of markers for renal fibrosis

Time frame:Samples collected at baseline (0 month), at 6 months and 24 months.

descriptive

Secondary/protocol endpoint

Glomerular filtration rate

Time frame:At baseline (0 month), at 6 months and 24 months.

eGFR, change

change from baseline, improvement

Secondary/protocol endpoint

Urine albumin-creatinine ratio

Time frame:At baseline (0 month), at 6 months and 24 months. Moreover, results from in-clinic laboratory assessments will be collected during the study period if available.

uACR, change

ratio, improvement

LOINC 9318-7

Other/protocol endpoint

eGFR

Time frame:At baseline (0 month), at 6 months and 24 months.

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint/low confidence

Amount of markers for oxidative stress and inflammation

Time frame:Samples collected at baseline (0 month), at 6 months and 24 months.

descriptive

Other/protocol endpoint

Blood pressure

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive, improvement

Other/protocol endpoint/low confidence

Troponin I

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Other/protocol endpoint

Blood lipids

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive, improvement

Safety / tolerability / PK

3 endpoints

Other/protocol endpoint

Thyroid-stimulating hormone (TSH)

Time frame:At baseline (0 month), at 6 months and 24 months.

Thyroid event

descriptive

Other/protocol endpoint/low confidence

Blood ketones

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Other/protocol endpoint

Electrolytes

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Myocardial oxygen consumption

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Secondary/protocol endpoint/low confidence

Myocardial external efficiency

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Secondary/protocol endpoint/low confidence

Myocardial perfusion

Time frame:At baseline (0 month), at 6 months and 24 month.

descriptive

Secondary/protocol endpoint/low confidence

Urinary extracellular vesicle

Time frame:On urine samples collected at baseline (0 month), at 6 months and 24 months. Differential protein abundance is assessed longitudinally (baseline vs 6 and 24 months) and cross-sectionally between treatments at matched time points.

descriptive

Other/protocol endpoint

Trombocytes

Time frame:At baseline (0 month), at 6 months and 24 months.

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

The Steno 1 study: Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes-rationale and protocol of the prospective, randomized, open-labelled multicentre study.
Diabetes, obesity & metabolism2025 Oct (month)PMID40726451doi:10.1111/dom.16606via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.