Type 1 Diabetes MellitusMICRONNCT07270172
The MICRON Study - A Steno 1 Substudy
An observational study of Type 1 Diabetes Mellitus, run by University of Aarhus at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 40 participants
- Where
- 5 sitesDenmark
- Study dates
- 27 Oct 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Sofie Husted Wilken, MD, PhD-student, 004523653656, shw@clin.au.dk
- Recruiting
Regionshospitalet Gødstrup
Gødstrup, 7400
Sofie H Wilken, MD, PhD student, 004523886635, shw@clin.au.dk
- Recruiting
Regionshospitalet Horsens
Horsens, 8700
Sofie H Wilken, MD, PhD student, 004523886635, shw@clin.au.dk
- Recruiting
Regionshospitalet Silkeborg
Silkeborg, 8600
Sofie H Wilken, MD, PhD student, 004523886635, shw@clin.au.dk
- Recruiting
Regionshospitalet Vibrg
Viborg, 8800
Sofie H Wilken, MD, PhD student, 004523886635, shw@clin.au.dk
About this study
Official title: Multifactorial Intervention to Reduce Cardiac and Renal Oxygen Need in Type 1 Diabetes (the MICRON Study) - A Steno 1 Substudy
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.
Read more
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.
Read the detailed description
In the MICRON study we will recruit participants from the ongoing CTIS approved Steno 1 study which is a prospective, cluster-randomized multicentre trial of 2000 persons with T1D. The Steno 1 study evaluates cardiovascular and renal effects of a multifactorial intervention vs. standard clinical care in subjects with type 1 diabetes (T1D) and established diabetic kidney disease (DKD), cardiovascular disease (CVD), heart failure, obesity or a >10% 5-year CVD risk using the Steno Risk Engine. The multifactorial intervention includes ambitious blood pressure and lipid targets as well as individualised pharmacological intervention with semglutide, sotagliflozin, and/or finerenone.
For the MICRON study we will recruit 20 persons from the ongoing Steno 1 study receiving multifactorial intervention as well as 20 persons from the Steno 1 study receiving standard care. No additional intervention is used for the MICRON study.
In the MICRON study each participant will undergo both [¹¹C]acetate PET/CT and [⁹⁹mTc]DTPAGFR measurements at baseline (inclusion) and again after 6 and 24 months of treatment (multifactorial intervention vs. standard care). At each of the three visits, blood and urine samples will be collected, along with anthropometric measurements.
The primary outcome variables, myocardial and renal oxygen consumption, will be assessed using [¹¹C]acetate PET/CT using a long axial field-of-view (LAFOV) PET scanner. Given that renal oxygen consumption is influenced by glomerular filtration rate (GFR), we will use [⁹⁹mTc]DTPA to accurately measure and account for variations in GFR when assessing renal oxygen consumption.
Three additional work packages WP2, WP3 and WP4 are to be conducted in collaboration with Steno Diabetes Centre Copenhagen, Monash University, Melbourne, Australia and the Department of Biomedicine, Aarhus University, Aarhus, Denmark investigating: WP2 Fibrosis, WP3 Oxidative stress and inflammation and WP4 Urinary extracellular vesicle proteomics.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetic Kidney Disease, Diabetes-Related Complications, Renal oxygenation, Cardiac oxygenation, Renal inflammation, Renal fibrosis, Cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies, Diabetes Complications, Nephritis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group in the Steno 1 study | Receiving the intensive treatment therapy in the Steno 1 Study. This consists of more ambitious blood pressure and lipid targets as well as individualised pharmacological intervention with GLP1 receptor agonist (semglutide), dual SGLT-1/2 inhibitor (sotagliflozin), and/or nonsteroidal mineralocorticoid receptor antagonist (finerenone). | |
| Control group in the Steno 1 study. | Receiving standart care in the Steno 1 Study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial oxygen consumption
Measured by [11C]acetate PET/CT Unit: volumen pr mass pr time
Measured: At baseline (0 month), at 6 months and 24 months.
Renal oxygen consumption
Measured by [11C]acetate PET/CT Unit: volumen pr mass pr time
Measured: At baseline (0 month), at 6 months and 24 months.
Secondary outcomes (8)
Myocardial external efficiency
Measured by [11C]acetate PET/CT Unit: %
Measured: At baseline (0 month), at 6 months and 24 months.
Myocardial perfusion
Measured by [11C]acetate PET/CT Unit: volumen pr mass pr time
Measured: At baseline (0 month), at 6 months and 24 month.
Renal perfusion
Measured by [11C]acetate PET/CT Unit: volumen pr mass pr time
Measured: At baseline (0 month), at 6 months and 24 months.
Amount of markers for oxidative stress and inflammation
Exploratory analysis on pathways of oxidative stress and inflammation known to be involved in diabetic cardiorenal damage. Analysis on blood and urine samples.
Measured: Samples collected at baseline (0 month), at 6 months and 24 months.
Amount of markers for renal fibrosis
Exploratory measurements of renal extracellular matrix metabolism. Measurement of formation of collagen type III and VI (PRO-C3 and PRO-C6), endotrophin, and the collagen III degradation product C3M in blood and urine.
Measured: Samples collected at baseline (0 month), at 6 months and 24 months.
Urinary extracellular vesicle
Unbiased, large-scale quantitative proteomic profiling of urinary extracellular vesicles (uEVs). Functional interpretation uses Gene Ontology and pathway enrichment analyses, with emphasis on inflammation, mitochondrial oxygen consumption, and oxidative-stress-related pathways.
Measured: 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.
Glomerular filtration rate
Measured by [99mTc]DTPA Unit: ml/(min*1,73 m^2)
Measured: At baseline (0 month), at 6 months and 24 months.
Urine albumin-creatinine ratio
Measured by urine spots Unit: None
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start27 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob A Østergaard, MD, PhD, Principal investigator, Steno Diabetes Centre Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270172
- Sponsor's protocol ID
- MICRON
- Acronym
- MICRON
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stougaard EB, Andersen MR, Bagger JI, Sondergaard E, Ostergaard JA, Curovic VR, Persson F, Almdal T, Mathiesen AS, Andries A, Bohl M, Norgaard LJ, Dejgaard TF, Dorfinger GH, Gustenhoff P, Gaede PH, Hamid YH, Johannesen HL, Juhl CB, Jorgensen ME, Kielgast U, Kofoed-Enevoldsen A, Lindhardt M, Mortensen LS, Thomsen HH, Stidsen J, Sorensen LP, Urhammer S, Rossing P; Steno 1 Study Group. 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 Obes Metab. 2025 Oct;27(10):5432-5443. doi: 10.1111/dom.16606. Epub 2025 Jul 29.
PubMed 40726451
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Intervention to Reduce Cardiac and Renal Oxygen Need in Type 1 Diabetes (the MICRON Study) - A Steno 1 Substudy
- ClinicalTrials.gov ID
- NCT07270172
- Acronym / sponsor ID
- MICRON / MICRON
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetic Kidney Disease, Diabetes-Related Complications, Renal oxygenation, Cardiac oxygenation, Renal inflammation, Renal fibrosis, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the MICRON study we will recruit participants from the ongoing CTIS approved Steno 1 study which is a prospective, cluster-randomized multicentre trial of 2000 persons with T1D. The Steno 1 study evaluates cardiovascular and renal effects of a multifactorial intervention vs. standard clinical care in subjects with type 1 diabetes (T1D) and established diabetic kidney disease (DKD), cardiovascular disease (CVD), heart failure, obesity or a >10% 5-year CVD risk using the Steno Risk Engine. The multifactorial intervention includes ambitious blood pressure and lipid targets as well as individualised pharmacological intervention with semglutide, sotagliflozin, and/or finerenone.
For the MICRON study we will recruit 20 persons from the ongoing Steno 1 study receiving multifactorial intervention as well as 20 persons from the Steno 1 study receiving standard care. No additional intervention is used for the MICRON study.
In the MICRON study each participant will undergo both [¹¹C]acetate PET/CT and [⁹⁹mTc]DTPAGFR measurements at baseline (inclusion) and again after 6 and 24 months of treatment (multifactorial intervention vs. standard care). At each of the three visits, blood and urine samples will be collected, along with anthropometric measurements.
The primary outcome variables, myocardial and renal oxygen consumption, will be assessed using [¹¹C]acetate PET/CT using a long axial field-of-view (LAFOV) PET scanner. Given that renal oxygen consumption is influenced by glomerular filtration rate (GFR), we will use [⁹⁹mTc]DTPA to accurately measure and account for variations in GFR when assessing renal oxygen consumption.
Three additional work packages WP2, WP3 and WP4 are to be conducted in collaboration with Steno Diabetes Centre Copenhagen, Monash University, Melbourne, Australia and the Department of Biomedicine, Aarhus University, Aarhus, Denmark investigating: WP2 Fibrosis, WP3 Oxidative stress and inflammation and WP4 Urinary extracellular vesicle proteomics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group in the Steno 1 study | – | –Receiving the intensive treatment therapy in the Steno 1 Study. This consists of more ambitious blood pressure and lipid targets as well as individualised pharmacological intervention with GLP1 receptor agonist (semglutide), dual SGLT-1/2 inhibitor (sotagliflozin), and/or nonsteroidal mineralocorticoid receptor antagonist (finerenone). |
| Control group in the Steno 1 study. | – | –Receiving standart care in the Steno 1 Study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial oxygen consumption
Time frame: At baseline (0 month), at 6 months and 24 months.
Measured by [11C]acetate PET/CT Unit: volumen pr mass pr time
Renal oxygen consumption
Time frame: At baseline (0 month), at 6 months and 24 months.
Measured by [11C]acetate PET/CT Unit: volumen pr mass pr time
8 secondary outcomes
Myocardial external efficiency
Time frame: At baseline (0 month), at 6 months and 24 months.
Myocardial perfusion
Time frame: At baseline (0 month), at 6 months and 24 month.
Renal perfusion
Time frame: At baseline (0 month), at 6 months and 24 months.
Amount of markers for oxidative stress and inflammation
Time frame: Samples collected at baseline (0 month), at 6 months and 24 months.
Amount of markers for renal fibrosis
Time frame: Samples collected at baseline (0 month), at 6 months and 24 months.
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.
Glomerular filtration rate
Time frame: At baseline (0 month), at 6 months and 24 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 40726451Stougaard EB, Andersen MR, Bagger JI, Sondergaard E, Ostergaard JA, Curovic VR, Persson F, Almdal T, Mathiesen AS, Andries A, Bohl M, Norgaard LJ, Dejgaard TF, Dorfinger GH, Gustenhoff P, Gaede PH, Hamid YH, Johannesen HL, Juhl CB, Jorgensen ME, Kielgast U, Kofoed-Enevoldsen A, Lindhardt M, Mortensen LS, Thomsen HH, Stidsen J, Sorensen LP, Urhammer S, Rossing P; Steno 1 Study Group. 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 Obes Metab. 2025 Oct;27(10):5432-5443. doi: 10.1111/dom.16606. Epub 2025 Jul 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob A Østergaard, MD, PhD principal investigator
Steno Diabetes Centre Aarhus
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by University of Aarhus at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie H Wilken, MD, PhD student (004523653656, shw@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial oxygen consumption (time frame: At baseline (0 month), at 6 months and 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07270172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.