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Can lowering cholesterol improve blood health in type 1 diabetes?

NCT ID NCT05641753

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 89 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mount Sinai School of Medicine

    RECRUITING

    New York, New York, 10029, United States

  • NYC Health + Hospitals/Bellevue

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • New York VA Hospital

    RECRUITING

    New York, New York, 10010, United States

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