Lowering cholesterol to assess health impacts in Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will recruit 125 participants with Type 1 Diabetes to evaluate the effects of cholesterol reduction on various health parameters. Participants will receive weekly injections of evolocumab along with daily oral atorvastatin or ezetimibe for one month. The study will analyze changes in platelet function, white blood cell gene expression, and vascular function through blood draws and optional vascular imaging tests. Continuous glucose monitoring will also be utilized to assess glycemic variability during the study period.

Why it matters

Who can join: the full rules

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)

Where it's running

• New York VA Hospital
  New York, New York, United States Recruiting
• NYC Health + Hospitals/Bellevue
  New York, New York, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting
• Mount Sinai School of Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Ira Goldberg, MD — NYU Langone Health
• Study coordinator: Ira Goldberg, MD
• Email: Ira.Goldberg@nyulangone.org
• Phone: 646-501-0589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.