Cholesterol-Lowering Drugs for Type 1 Diabetes
(CHORD1 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like antithrombotic therapy, aspirin, NSAIDs, or PCSK9 inhibitors.
What data supports the effectiveness of the drugs used in the clinical trial for cholesterol-lowering in type 1 diabetes?
Research shows that atorvastatin, a drug used in the trial, not only lowers cholesterol but may also help preserve some insulin-producing cells in people newly diagnosed with type 1 diabetes. Additionally, ezetimibe and evolocumab, other drugs in the trial, are effective in lowering bad cholesterol (LDL-C) and reducing heart disease risk, which is beneficial for managing diabetes-related complications.12345
Is it safe to use cholesterol-lowering drugs like Atorvastatin, Evolocumab, and Ezetimibe in humans?
Cholesterol-lowering drugs such as Atorvastatin, Evolocumab, and Ezetimibe have been studied for safety in humans. Common side effects of statins like Atorvastatin include muscle symptoms and a risk of new-onset diabetes, but these do not outweigh the benefits. Evolocumab and Ezetimibe are generally safe, with Evolocumab being used for patients with high cholesterol not controlled by other drugs, and Ezetimibe showing no significant interactions with most other medications.16789
How does the drug combination of Atorvastatin, Evolocumab, and Ezetimibe differ from other treatments for type 1 diabetes?
This drug combination is unique because it targets cholesterol management in type 1 diabetes, which is not commonly addressed. Atorvastatin may help preserve beta cell function, while Ezetimibe and Evolocumab are effective in lowering cholesterol absorption and LDL levels, respectively, offering a comprehensive approach to reducing cardiovascular risk in these patients.23101112
What is the purpose of this trial?
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 heal2. 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) and3. Analyze the effect of reducing the cholesterol levels in the blood on vascular or blood vessel function.
Research Team
Ira Goldberg, MD
Principal Investigator
NYU Langone Health
Eligibility Criteria
This trial is for adults aged 18 to 89 with Type 1 Diabetes and LDL cholesterol over 100mg/dl. They must have a confirmed diagnosis of T1D, not be pregnant, and cannot have been hospitalized or had an infection in the last month. Participants should not be on aspirin, NSAIDs within the past three days, immunosuppressives, antithrombotics, or PCSK9 inhibitors.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly injections of PCSK9i (evolocumab) and daily oral pills of atorvastatin or ezetimibe for 1 month
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atorvastatin Calcium Tablets
- Evolocumab Cartridge
- Ezetimibe Tablets
Atorvastatin Calcium Tablets is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Prevention of cardiovascular disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator