RecruitingPhase 4NCT05641753

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

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


Sponsor

NYU Langone Health

Enrollment

125 participants

Start Date

Dec 6, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria11

  • 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

Exclusion Criteria14

  • Established cardiovascular disease on antithrombotic therapy
  • Triglycerides \>400mg/dl
  • Use of a PCSK9 inhibitor
  • Recent infection in the past 30 days
  • Any hospitalization in the past 30 days
  • Use of immunosuppressive therapy
  • Use of any antithrombotic therapy
  • Use of aspirin
  • Use of NSAID within the past 72 hours
  • Pregnancy
  • Anemia (hemoglobin \< 9 g/dl) or thrombocytopenia (platelet count \<75), or thrombocytosis (platelet count \>600)
  • 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)

Interventions

DRUGEvolocumab Cartridge

Injectable PCSK9 inhibitor.

DRUGAtorvastatin Calcium Tablets

HMG-CoA reductase inhibitor for oral use.

DRUGEzetimibe Tablets

Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.

DRUG18F-FDG

Optional procedure. Positron emission tomography (PET) and computed tomography (CT) imaging to assess vascular inflammation and related anatomy requires injection of the PET tracer 18F-FDG. 18F-FDG is an FDA-approved analogue of sugar, routinely used to evaluate elevated metabolism in tissues, including increased metabolism due to inflammatory cells. A standard dose of 7.0 mSv will be administered.

DEVICEAngiocatheter 20IV

Optional procedure (endothelial cell harvesting). An angiocatheter ≤ 21 gauge will be inserted into a peripheral vein on the upper extremity using aseptic technique. A 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be then advanced into the angiocatheter, to a distance of 4cm beyond the end of the angiocatheter.

DEVICEJ-Wire

Optional procedure (endothelial cell harvesting). Either a 0.021in. diameter J-shaped wire (Daig, Minnetonka, MN) or a 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be used.

DEVICEGlycoCheck Glycocalyx Measurement Software

Optional procedure (assessment of vascular function). Video microscope developed by GlycoCheck.


Locations(4)

New York VA Hospital

New York, New York, United States

NYC Health + Hospitals/Bellevue

New York, New York, United States

NYU Langone Health

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05641753


Related Trials