Multifactorial Intervention to Reduce Cardiac and Renal Oxygen Need in Type 1 Diabetes (the MICRON Study) - A Steno 1 Substudy
MICRON Study: Investigating Heart and Kidney Health in Type 1 Diabetes
Plain English Summary
The MICRON Study - A Steno 1 Substudy is a Not Applicable clinical trial sponsored by University of Aarhus studying Type 1 Diabetes Mellitus. This observational study compares how a special treatment plan affects the oxygen use of the heart and kidneys in people with Type 1 Diabetes. It is for individuals aged 40 and older with Type 1 Diabetes who also have existing heart or kidney issues, or are at high risk for cardiovascular disease. Participants will have specialized scans and blood/urine tests at the start, 6 months, and 24 months after joining a related main study. There are no direct alternatives to participating in this specific observational substudy, but standard care for Type 1 Diabetes and its complications is the alternative to the intervention being studied in the main trial. The trial aims to enroll 40 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 40 or older, have Type 1 Diabetes diagnosed before age 30 (or with specific criteria if diagnosed later), and have had diabetes for over 10 years. You must also have chronic kidney disease, a history of heart problems (like heart attack or heart failure), or a high risk of cardiovascular disease. Women of childbearing potential need to use effective contraception. You cannot join if you have Type 2 Diabetes, a history of pancreatitis, a very low BMI, are pregnant or breastfeeding, have a history of substance abuse, or are currently in another drug study. This trial is studying Type 1 Diabetes Mellitus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure how much oxygen your heart and kidneys use, helping to determine if the new treatment plan can make these vital organs work more efficiently and with less strain. The specific primary outcome measures are: Myocardial oxygen consumption (At baseline (0 month), at 6 months and 24 months.); Renal oxygen consumption (At baseline (0 month), at 6 months and 24 months.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to understand if a comprehensive treatment approach can reduce the strain on the heart and kidneys in people with Type 1 Diabetes, addressing a gap in preventin This research targets Type 1 Diabetes Mellitus, where improved treatment options are needed.
Investor Insight
This observational substudy, linked to a larger intervention trial, focuses on a well-defined patient group with significant unmet needs in managing cardiovascular and renal complications of Type 1 Di
Is This Trial Right for Me?
Ask your doctor about the specific intervention being tested in the main Steno 1 study and how this substudy relates to your overall care. Participation involves undergoing several specialized tests, including PET/CT scans and blood/urine sample collections, at specific time points over two years. Be prepared for regular visits to the study sites for these assessments. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 40 participants
Primary Outcomes
- Myocardial oxygen consumption (At baseline (0 month), at 6 months and 24 months.)
- Renal oxygen consumption (At baseline (0 month), at 6 months and 24 months.)
Secondary Outcomes
- Myocardial external efficiency (At baseline (0 month), at 6 months and 24 months.)
- Myocardial perfusion (At baseline (0 month), at 6 months and 24 month.)
- Renal perfusion (At baseline (0 month), at 6 months and 24 months.)
- Amount of markers for oxidative stress and inflammation (Samples collected at baseline (0 month), at 6 months and 24 months.)
- Amount of markers for renal fibrosis (Samples collected at baseline (0 month), at 6 months and 24 months.)
Full 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.
Trial Locations
- Aarhus University Hospital, Aarhus N, Denmark
- Regionshospitalet Gødstrup, Gødstrup, Denmark
- Regionshospitalet Horsens, Horsens, Denmark
- Regionshospitalet Silkeborg, Silkeborg, Denmark
- Regionshospitalet Vibrg, Viborg, Denmark
Frequently Asked Questions
What is clinical trial NCT07270172?
NCT07270172 is a Not Applicable OBSERVATIONAL study titled "The MICRON Study - A Steno 1 Substudy." It is currently recruiting and is sponsored by University of Aarhus. The trial targets enrollment of 40 participants.
What conditions does NCT07270172 study?
This trial investigates treatments for Type 1 Diabetes Mellitus. The primary condition under study is Type 1 Diabetes Mellitus.
What does Not Applicable mean for NCT07270172?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07270172?
This trial is currently "Recruiting." It started on 2025-10-27. The estimated completion date is 2028-12.
Who is sponsoring NCT07270172?
NCT07270172 is sponsored by University of Aarhus. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07270172?
The trial aims to enroll 40 participants. The trial is currently recruiting and accepting new participants.
How is NCT07270172 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07270172?
The primary outcome measures are: Myocardial oxygen consumption (At baseline (0 month), at 6 months and 24 months.); Renal oxygen consumption (At baseline (0 month), at 6 months and 24 months.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07270172 being conducted?
This trial is being conducted at 5 sites, including Aarhus N; Gødstrup; Horsens; Silkeborg and 1 more sites (Denmark).
Where can I find official information about NCT07270172?
The official record for NCT07270172 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07270172. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07270172 testing in simple terms?
This observational study compares how a special treatment plan affects the oxygen use of the heart and kidneys in people with Type 1 Diabetes. It is for individuals aged 40 and older with Type 1 Diabetes who also have existing heart or kidney issues, or are at high risk for cardiovascular disease.
Why is this trial significant?
This trial is important because it aims to understand if a comprehensive treatment approach can reduce the strain on the heart and kidneys in people with Type 1 Diabetes, addressing a gap in preventin
What are the potential risks of participating in NCT07270172?
The main risks are associated with the imaging procedures (PET/CT scans), which involve radiation exposure, though generally considered low. Potential side effects from blood draws include bruising or minor discomfort. There are no study drugs administered in this substudy; risks are primarily related to the diagnostic procedures. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07270172?
Ask your doctor about the specific intervention being tested in the main Steno 1 study and how this substudy relates to your overall care. Participation involves undergoing several specialized tests, including PET/CT scans and blood/urine sample collections, at specific time points over two years. Be prepared for regular visits to the study sites for these assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07270172 signal from an investment perspective?
This observational substudy, linked to a larger intervention trial, focuses on a well-defined patient group with significant unmet needs in managing cardiovascular and renal complications of Type 1 Di This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have specialized scans and blood/urine tests at the start, 6 months, and 24 months after joining a related main study. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Type 1 Diabetes Mellitus Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.