Cholesterol Lowering and Residual Risk in Diabetes, Type 1 (NCT05641753) | Clinical Trial Compass
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
United States125 participantsStarted 2022-12-06
Plain-language summary
This is a prospective, interventional, cohort study, meaning that researchers will follow and observe a group of enrolled study participants over a period of time (one to two months) to gather information and record any developments of the outcomes in question.
This study will recruit 125 participants with Type 1 Diabetes (T1D) to:
1. Analyze the effect of reducing the cholesterol levels in the blood on platelet function. (Platelets are small cells in the blood which help form blood clots to slow or stop bleeding and to help wounds heal
2. Analyze the effect of reducing the cholesterol levels in the blood on While Blood Cell (WBC) gene expression, (White Blood Cells are part of the body's immune system which help the body fight infection and other diseases) and
3. Analyze the effect of reducing the cholesterol levels in the blood on vascular or blood vessel function.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year)
✓. American Diabetes Association Criteria for diagnosis of diabetes (Must meet at least 1 of the following criteria):
✓. History of T1D (due to autoimmune β-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood). Autoimmune markers include islet cell autoantibodies and autoantibodies to GAD (glutamic acid decarboxylase, GAD65), insulin, the tyrosine phosphatases islet antigen 2 (IA-2) and IA-2β, and zinc transporter 8, OR;
✓. Diagnosis of T1D and confirmed by review of records by 2 separate clinical members of the study team
✓. Age ≥ 18 \& \< 90
✓. LDL-C \>100mg/dl
✓. Able and willing to provide written informed consent for the study
Exclusion criteria
✕. Established cardiovascular disease on antithrombotic therapy
What they're measuring
1
Change in Monocyte Platelet Aggregation (MPA) from Baseline
Timeframe: Baseline, Week 4
2
Change in Light Transmission Aggregation (LTA) from Baseline