Platelet aggregation and aspirin low response in type one diabetes and the association with vascular damage and diabetic kidney disease

Phase 1

• Conditions: Prevention of cardiovascular disease in persons with type 1 diabetes; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-004772-19-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-16
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Inclusion criteria (T1D)
•Type 1 diabetes
•Male and female participants, >18 years of age
•Capable of giving informed consent

Inclusion criteria (healthy controls)
•Healthy, as judged by the exclusion criteria’s below
•Male and female participants, >18 years of age
•Capable of giving informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Exclusion criteria (T1D)
•Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
•Non-diabetic kidney disease
•Treatment with adenosine diphosphate (ADP)-receptor inhibitors, NSAID within the past 14 days, fish oil or other antithrombotic treatment (vitamin K antagonists and NOAKs)
•Liver disease (liver cirrhosis with current impaired liver function defined as alanine-aminotransferase (ALT) more than two times the upper limit at last control)
•High risk of thrombosis:
oStroke, TIA or drug eluting stent within the last 6 months
oAcute coronary syndrome within the last 6 weeks or within 12 months from complications to acute coronary syndrome
•Known hypersensitivity or intolerance to aspirin
•Persons who, in the judgement of the investigator, are incapable of participating.
•Participation in another intervention study

Exclusion criteria (healthy controls)
•Chronic systemic disease
•Intake of any antithrombotic medication
•Intake of fish oil
•Intake of NSAIDs within the past 14 days
•Pregnancy or breastfeeding (urine HCG is performed in all fertile women)
•Persons who, in the judgement of the investigator, are incapable of participating
•Participation in another intervention study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified