Actively Recruiting
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Led by NYU Langone Health · Updated on 2025-12-29
125
Participants Needed
4
Research Sites
242 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 1 Diabetes for at least 1 year based on American Diabetes Association criteria or physician judgment
- Diagnosis confirmed by review of records by two clinical study team members
- Age 18 to less than 90 years
- LDL cholesterol greater than 100 mg/dL
- Able and willing to provide written informed consent
You will not qualify if you...
- Established cardiovascular disease on antithrombotic therapy
- Triglycerides greater than 400 mg/dL
- Use of PCSK9 inhibitors
- Recent infection within the past 30 days
- Any hospitalization within the past 30 days
- Use of immunosuppressive therapy
- Use of any antithrombotic therapy
- Use of aspirin
- Use of NSAIDs within the past 72 hours
- Pregnancy
- Anemia with hemoglobin less than 9 g/dL, thrombocytopenia with platelets less than 75, or thrombocytosis with platelets greater than 600
- History of bleeding disorders
- Chronic kidney disease with creatinine clearance less than 30 ml/min
- Type 2 Diabetes, monogenic diabetes syndromes, or diabetes related to diseases of the exocrine pancreas such as pancreatitis, trauma, pancreatectomy, neoplasia, cystic fibrosis, or hemochromatosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
New York VA Hospital
New York, New York, United States, 10010
Actively Recruiting
2
NYC Health + Hospitals/Bellevue
New York, New York, United States, 10016
Actively Recruiting
3
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
4
Mount Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
Research Team
I
Ira Goldberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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