Actively Recruiting
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Led by Steno Diabetes Center Copenhagen · Updated on 2025-01-10
2000
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Steno Diabetes Center Copenhagen
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.
CONDITIONS
Official Title
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Given written informed consent
- Male or female patients aged 40 years or older with type 1 diabetes diagnosed before age 30 with insulin from onset, or if diagnosed after 30, insulin from onset plus diabetic ketoacidosis or positive autoantibodies, with diabetes duration over 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 heart attack, stroke, or angina), or history of heart failure, or obesity grade 2 or 3 (BMI >35 kg/m2), or 10-year cardiovascular disease risk over 10% according to the Steno Type 1 Risk Engine
- Fertile females must use highly effective chemical, hormonal, or mechanical contraception during the study and for at least 2 months after stopping study drugs, or be menopausal, surgically sterilized, or hysterectomized for at least 12 months prior to screening
- Ability to communicate with the investigator and understand informed consent
You will not qualify if you...
- Type 2 diabetes, MODY, or secondary diabetes
- History of pancreatitis
- Body mass index less than 18.5 kg/m2
- Females of childbearing potential who are pregnant, breastfeeding, planning pregnancy, or not using adequate contraception
- Known or suspected abuse of alcohol or recreational drugs
- Participation in another intervention study
- Chronic kidney disease stage 5
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
2
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
Actively Recruiting
Research Team
F
Frederik Persson, MD, DMSc
CONTACT
E
Elisabeth Stougaard, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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