Recruiting

Cholesterol Lowering

Sponsor:

NYU Langone Health

Code:

NCT05641753

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Evolocumab Cartridge

Atorvastatin Calcium Tablets

Ezetimibe Tablets

18F-FDG

Angiocatheter 20IV

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Study ID

NCT05641753

Start date

Dec 6, 2022

Status verified date

Dec, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year)

1. American Diabetes Association Criteria for diagnosis of diabetes (Must meet at least 1 of the following criteria):

  • 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

Exclusion Criteria:

1. Established cardiovascular disease on antithrombotic therapy
2. Triglycerides >400mg/dl
3. Use of a PCSK9 inhibitor
4. Recent infection in the past 30 days
5. Any hospitalization in the past 30 days
6. Use of immunosuppressive therapy
7. Use of any antithrombotic therapy
8. Use of aspirin
9. Use of NSAID within the past 72 hours
10. Pregnancy
11. Anemia (hemoglobin < 9 g/dl) or thrombocytopenia (platelet count <75), or thrombocytosis (platelet count >600)
12. A history of hemorrhagic diathesis
13. Chronic kidney disease (CrCl < 30ml/min)
14. T2D, monogenic diabetes syndromes, or diabetes in the context of disease of the exocrine pancreas (such as pancreatitis, trauma or pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis)

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 4-Week LDL-Cholesterol (LDL-C)-Reduction Treatment

Treatment consists of: Evolocumab (140 mg; 2 injections, one administered at baseline visit and another self-administered 2 weeks later), and; Atorvastatin (up to 80mg dose; 1 tab per day for 30 days, starting at baseline visit post-assessment). Participants with statin intolerance will be provided with a 1-month supply of ezetimibe 10 mg to replace Evolocumab and Atorvastatin.

  • Additional procedures: Blood draws.
  • Optional procedures: Glycocalyx testing, PET/CT, or Endothelial Cell Collection.

Interventions

Evolocumab Cartridge

Injectable PCSK9 inhibitor.

Atorvastatin Calcium Tablets

HMG-CoA reductase inhibitor for oral use.

Ezetimibe Tablets

Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.

18F-FDG

Optional procedure. Positron emission tomography (PET) and computed tomography (CT) imaging to assess vascular inflammation and related anatomy requires injection of the PET tracer 18F-FDG. 18F-FDG is an FDA-approved analogue of sugar, routinely used to evaluate elevated metabolism in tissues, including increased metabolism due to inflammatory cells. A standard dose of 7.0 mSv will be administered.

Angiocatheter 20IV

Optional procedure (endothelial cell harvesting). An angiocatheter ≤ 21 gauge will be inserted into a peripheral vein on the upper extremity using aseptic technique. A 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be then advanced into the angiocatheter, to a distance of 4cm beyond the end of the angiocatheter.

J-Wire

Optional procedure (endothelial cell harvesting). Either a 0.021in. diameter J-shaped wire (Daig, Minnetonka, MN) or a 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be used.

GlycoCheck Glycocalyx Measurement Software

Optional procedure (assessment of vascular function). Video microscope developed by GlycoCheck.

Primary outcome measure

  • Change in Monocyte Platelet Aggregation (MPA) from Baseline [ Time Frame: Baseline, Week 4 ]
  • Change in Light Transmission Aggregation (LTA) from Baseline [ Time Frame: Baseline, Week 4 ]

Central Contacts and Locations

Central contacts

Locations

New York VA Hospital

Recruiting

New York, New York, United States, 10010

NYC Health + Hospitals/Bellevue

Recruiting

New York, New York, United States, 10016

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Mount Sinai School of Medicine

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Zahi Fayad

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-29.