NCT07270172

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2025-10-27
• Primary completion: 2028-07-01
• Completion: 2028-12-01
• First posted: 2025-12-08
• Last updated: 2026-02-02

Locations

5 sites across 1 country: Denmark