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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai School of Medicine
RECRUITING
New York
New York VA Hospital
RECRUITING
New York
NYC Health + Hospitals/Bellevue
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Ira Goldberg, MD
Ira.Goldberg@nyulangone.org
646-501-0589
Time Frame
Start Date: 2022-12-06
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 125
Treatments
Experimental: 4-Week LDL-Cholesterol (LDL-C)-Reduction Treatment
Treatment consists of: Evolocumab (140 mg; 2 injections, one administered at baseline visit and another self-administered 2 weeks later), and; Atorvastatin (up to 80mg dose; 1 tab per day for 30 days, starting at baseline visit post-assessment). Participants with statin intolerance will be provided with a 1-month supply of ezetimibe 10 mg to replace Evolocumab and Atorvastatin.~* Additional procedures: Blood draws.~* Optional procedures: Glycocalyx testing, PET/CT, or Endothelial Cell Collection.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov