Can lowering cholesterol improve blood health in type 1 diabetes?
NCT ID NCT05641753
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how reducing cholesterol levels affects blood cells and blood vessels in people with type 1 diabetes. Researchers will follow 125 participants for one to two months to measure changes in platelet activity, immune cell function, and blood vessel health. The goal is to better understand the benefits of cholesterol-lowering beyond heart health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mount Sinai School of Medicine
RECRUITINGNew York, New York, 10029, United States
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NYC Health + Hospitals/Bellevue
RECRUITINGNew York, New York, 10016, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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New York VA Hospital
RECRUITINGNew York, New York, 10010, United States
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Other studies related to the condition(s) this trial covers.
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- Can an automated pancreas system make type 1 diabetes safer in the real world?