No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 89
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Other
Participants needed
125 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for adults with Type 1 Diabetes who want to help researchers study how lowering cholesterol affects various health factors. Participants will be followed for one to two months to gather information.
Are You a Good Fit for This Trial?
Rules you outEstablished cardiovascular diseaseChronic kidney diseaseType 2 diabetes
You may be able to join if
I have Type 1 Diabetes diagnosed for at least 1 year.
I am between 18 and 90 years old.
My LDL cholesterol is greater than 100 mg/dl.
I can provide signed consent to participate.
You may not be able to join if
I have heart disease and use blood-thinning medication.
My triglycerides are greater than 400 mg/dl.
I have had an infection in the past 30 days.
I have been hospitalized in the past 30 days.
I am currently pregnant.
I have a severe kidney condition.
I have anemia or abnormal platelet counts.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
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 ≥12…
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)
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