PLatelet aggregation and Aspirin low response in Type One Diabetes and the association with vascular damage and diabetic Nephropathy

Phase 2

Not yet recruiting

Conditions: Atherosclerotic cardiovascular disease
Type 1 diabete
Diabetic kidney disease

Registration Number: 2024-520324-29-00

Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary: Investigate platelet aggregation in T1D without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls. Platelet aggregation is determined by arachidonic acid expressed as area under the curve.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 332

Inclusion Criteria

Type 1 diabetes. (Only for the type 1 diabetes population.)

Male and female participants > 18 years of age.

Capable of giving informed consent

Exclusion Criteria

Pregnancy or breastfeeding

Intake of any antithrombotic medication or fish oil, or intake of NSAIDs within the past 14 days. (Only healthy controls.)

Persons who, in the judgement of the investigator, are incapable of participating.

Participation in another intervention study

Non-diabetic kidney disease. (Only the type 1 diabetes population.)

Treatment with adenosine diphosphate ADP-receptor inhibitors, NSAID within the past 14 days, fish oil or other antithrombotic treatment, e.g. vitamin K antagonists and NOAKs. Only the type 1 diabetes population.

Liver disease (liver cirrhosis with current impaired liver function defined as ALAT more than two times the upper limit at last control.) (Only the type 1 diabetes population.)

High risk of thrombosis, i.e., Stroke, TIA or drug eluting stent within the last 6 months or acute coronary syndrome within the last 6 weeks or within 12 months from complications to acute coronary syndrome. (Only the type 1 diabetes population.)

Known hypersensitivity or intolerance to aspirin. (Only the type 1 diabetes population.)

Chronic systemic disease. (Only healthy controls.)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigate platelet aggregation in T1D without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls. Platelet aggregation is determined by arachidonic acid expressed as area under the curve.		Investigate platelet aggregation in T1D without/off aspirin treatment, stratified according to degree of albuminuria, compared to healthy controls. Platelet aggregation is determined by arachidonic acid expressed as area under the curve.

Secondary Outcome Measures

Name	Time	Method
Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls.		Investigate platelet aggregation after a minimum of seven days aspirin treatment in T1D, stratified according to degree of albuminuria, compared to healthy controls.
Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D.		Determine the prevalence of plaques and plaque volume in the carotid arteries in subjects with T1D.
Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D.		Examine the association between platelet aggregation and the plaque volume in the carotid arteries in subjects with T1D.
Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors.		Investigate whether platelet aggregation or plaque volume can predict progression in plaque volume after two years, independently of other risk factors.
Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.		Investigate if platelet aggregation and change in plaque volume can predict CVD outcome in register-based follow up, independently of other risk factors.
Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries.		Investigate endothelial function and inflammation in T1D and examine the association with platelet aggregation and plaque volume in the carotid arteries.

Trial Locations

Locations (1): Steno Diabetes Center Copenhagen
🇩🇰
Herlev, Denmark
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark
Peter Rossing
Site contact
+4530913383
peter.rossing@regionh.dk