Cholesterol Lowering and Residual Risk in Diabetes, Type 1

Launched by NYU LANGONE HEALTH · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how lowering cholesterol levels in people with Type 1 Diabetes (T1D) affects their blood cells and blood vessel function. Researchers want to see if reducing cholesterol can change how well platelets (which help with blood clotting) work, how white blood cells (which fight infections) respond, and how well blood vessels function. The study will involve 125 participants and will last for one to two months.

To join the study, participants should be between 18 and 90 years old, have been diagnosed with T1D for at least a year, and have high levels of LDL cholesterol (the "bad" cholesterol). Participants will need to give their consent to be part of the study and will be monitored closely throughout. However, certain individuals, such as those with specific heart conditions or recent infections, may not be eligible to participate. Overall, this trial aims to gather valuable information that could help improve health outcomes for people living with Type 1 Diabetes.

Gender

ALL

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 ≥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)

Trial Officials