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Cholesterol Lowering in Type 1 Diabetes

This study is looking at how lowering cholesterol levels affects blood clotting (platelet function) and immune cells (white blood cells) in people with Type 1 Diabetes. You would receive weekly injections of Evolocumab and daily oral Atorvastatin or Ezetimibe for one month. Researchers will measure changes in Monocyte Platelet Aggregation (MPA) and Light Transmission Aggregation (LTA) to see if the treatments are successful. The study is open to individuals aged 18 to 89 who have had Type 1 Diabetes for at least one year. The current recruitment status is unclear, but 125 participants are planned.

Study design
This is an interventional cohort study, meaning researchers will observe 125 participants over one to two months while they receive specific treatments.
What's involved
You would receive weekly injections and daily oral medication for one month. This involves blood draws and optional vascular studies, including a non-invasive test under the tongue, PET/CT scans, and endothelial cell collection.
Compensation
Not stated in the trial record.
Follow-up
Changes in blood clotting are measured at baseline and Week 4.

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NCT05641753

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

Recruiting
PHASE4Ages 18–89Interventional
NYU Langone Health
~125 participants
Updated 2025-12-29 on ClinicalTrials.gov
What's tested:Evolocumab CartridgeAtorvastatin Calcium TabletsEzetimibe Tablets18F-FDGAngiocatheter 20IVJ-Wire

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Monocyte Platelet Aggregation (MPA) from Baseline
Measured over Baseline, Week 4
+1 more outcome measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

4 sites across 1 states
New York4

Study leadership

  • Ira Goldberg, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Ira Goldberg, MD
[email protected]
646-501-0589
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

i. FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours, OR;
ii. 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, OR;
iii. A1C ≥6.5% (48 mmol/mol), OR;
iv. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L), AND; 2. 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; 3. Diagnosis of T1D and confirmed by review of records by 2 separate clinical members of the study team 2. Age ≥ 18 \& \< 90 3. LDL-C \>100mg/dl 4. Able and willing to provide written informed consent for the study

What this trial measures

  • Change in Monocyte Platelet Aggregation (MPA) from BaselineBaseline, Week 4

    Measurement of platelet activity. Assessed via patient blood sample.

  • Change in Light Transmission Aggregation (LTA) from BaselineBaseline, Week 4

    Measurement of platelet activity. Assessed via patient blood sample.