Fact CheckerSign in

NCT05641753RecruitingPhase 4

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

CHORD1 - CHOlesterol Lowering and Residual Risk in Diabetes, Type 1

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
125 (estimated)
First submitted
29 Nov 2022
Start date
6 Dec 2022
Primary completion date
1 Jul 2027
Lead sponsor
NYU Langone Health
NCT number
NCT05641753

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 125
  • From 6 Dec 2022 to the primary completion date, 1 Jul 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of a PCSK9 inhibitor
  • Use of immunosuppressive therapy
  • Use of any antithrombotic therapy

Other illness

  • Established cardiovascular disease on antithrombotic therapy
  • Recent infection in the past 30 days
  • A history of hemorrhagic diathesis
  • Chronic kidney disease (CrCl \< 30ml/min)
  • 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)

Lab values

  • Anemia (hemoglobin \< 9 g/dl) or thrombocytopenia (platelet count \<75), or thrombocytosis (platelet count \>600)

Other

  • Triglycerides \>400mg/dl
  • Any hospitalization in the past 30 days
  • Use of aspirin
  • Use of NSAID within the past 72 hours
  • Pregnancy

Who the study is looking for

  • Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year)
    • 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;
    • 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;
    • Diagnosis of T1D and confirmed by review of records by 2 separate clinical members of the study team
  • Age ≥ 18 \& \< 90
  • LDL-C \>100mg/dl
  • Able and willing to provide written informed consent for the study

Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
New York VA Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
NYC Health + Hospitals / Bellevue
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Mount Sinai School of Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.