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Not yet taking people in DenmarkPhase 2

Studies platelet clotting and aspirin response in people with type 1 diabetes

Examines platelet clotting in adults with type 1 diabetes, grouped by kidney protein levels.

Key facts

Who runs it
Steno Diabetes Center Copenhagen
Where
Herlev, DenmarkSee the site
Registry title
PLatelet aggregation and Aspirin low response in Type One Diabetes and the association with vascular damage and diabetic Nephropathy
Status
Not yet recruiting
Phase
Phase 2
People taking part
332 people, planned
Started
12 May 2020
Expected to end
31 Dec 2030
Type of study
Interventional
Record updated
22 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 diabetes, and also healthy adults as a comparison group, to study how blood platelets clump together with and without aspirin.

Age
Over 18 years
Sex
All sexes
Disease stage
Type 1 diabetes (for the diabetes group). The record also mentions groups by amount of albumin in the urine.
Earlier treatment
People with type 1 diabetes cannot have had treatment with ADP-receptor inhibitors, NSAIDs within the past 14 days, fish oil or other blood-thinning treatment. Healthy controls cannot have taken any blood-thinning medicine or fish oil, or NSAIDs within the past 14 days.

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Taking part in another intervention study
  • Kidney disease not caused by diabetes (diabetes group)
  • Liver disease with impaired liver function (diabetes group)
  • High risk of blood clots, such as recent stroke, TIA, drug-eluting stent or acute coronary syndrome (diabetes group)

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Type 1 diabetes. (Only for the type 1 diabetes population.)
  • Male and female participants > 18 years of age
  • Capable of giving informed consent

Who cannot take part

  • Intake of any antithrombotic medication or fish oil, or intake of NSAIDs within the past 14 days. (Only healthy controls.)
  • 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
  • Non-diabetic kidney disease. (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.)
  • Pregnancy or breastfeeding
  • Persons who, in the judgement of the investigator, are incapable of participating
  • Participation in another intervention study

Where in Denmark

  • Steno Diabetes Center CopenhagenHerlev, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
PLatelet aggregation and Aspirin low response in Type One Diabetes and the association with vascular damage and diabetic Nephropathy
Plain-language title
Studies platelet clotting and aspirin response in people with type 1 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
22 January 2025