NCT05641753 Cholesterol Lowering and Residual Risk in Diabetes, Type 1
| NCT ID | NCT05641753 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | NYU Langone Health |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2022-12-06 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 125 participants in total. It began in 2022-12-06 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Ira Goldberg, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05641753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05641753 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05641753 currently recruiting?
Yes, NCT05641753 is actively recruiting participants. Contact the research team at Ira.Goldberg@nyulangone.org for enrollment information.
Where is the NCT05641753 trial being conducted?
This trial is being conducted at New York, United States, New York, United States, New York, United States, New York, United States.
Who is sponsoring the NCT05641753 clinical trial?
NCT05641753 is sponsored by NYU Langone Health. The principal investigator is Ira Goldberg, MD at NYU Langone Health. The trial plans to enroll 125 participants.
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