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Statins

Cholesterol-Lowering Drugs for Type 1 Diabetes (CHORD1 Trial)

Q: Is there any way that I can become a part of this clinical trial?

This medical trial is enrolling 125 people with <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">Type 1 diabetes</a> Mellitus, aged between 18 and 89. To qualify for enrollment, patients must meet a range of criteria such as minimum A1C level or random plasma glucose levels, LDL-C higher than 100mg/dl, diagnosis confirmed by two clinical team members and agreement to provide written consent. Additionally candidates must have had the condition diagnosed at least one year prior; verified via FPG ≥126 mg/dL (7.0 mmol/L), 2-h PG ≥200 mg/dL (11.1 mmol/L) during an OGTT or autoimmune markers like GAD

Q: Is it feasible to enroll in this research project presently?

At the present moment, this clinical trial is actively searching for patients to take part. It was initially posted on November 16th 2022 and underwent its most recent update on November 29th of the same year.

Q: Are there any age restrictions on participation in this experiment?

To be eligible for this investigation, the patient must fall within the age bracket of 18-89. For participants younger than 18, there are 220 relevant clinical trials available; those over 65 have access to 931 alternate studies.

Q: What is the upper limit of enrollees for this clinical trial?

Affirmative. According to clinicaltrials.gov, this research endeavour was initially posted on November 16th 2022 and has recently been revised on the 29th of the same month. 125 participants are sought from 3 distinct medical institutions.

Q: How might a four-week LDL-C reduction regimen impact patient health?

This 4-Week LDL-<a href="https://www.withpower.com/clinical-trials/cholesterol">Cholesterol</a> (LDL-C)-Reduction Treatment has a safety score of 3, indicating that it is approved for use in clinical practice.

Phase 4

Recruiting

Led By Ira Goldberg, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meeting at least 1 of the following American Diabetes Association Criteria for diagnosis of diabetes: FPG ≥126 mg/dL (7.0 mmol/L), 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT, A1C ≥6.5%, or random plasma glucose ≥200 mg/dL (11.1 mmol/L) with classic symptoms of hyperglycemia or hyperglycemic crisis

Age ≥ 18 & < 90

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4

Awards & highlights

CHORD1 Trial Summary

This trial will look at how reducing cholesterol affects platelets, WBCs & blood vessels in people with T1D.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests how lowering cholesterol affects platelet function (which helps blood clot), White Blood Cell gene expression (important for fighting infections), and blood vessel function in people with Type 1 Diabetes using Evolocumab Cartridge combined with Atorvastatin Calcium Tablets or Ezetimibe Tablets.See study design

What are the potential side effects?

Potential side effects may include injection site reactions from Evolocumab Cartridge; muscle pain, weakness from Atorvastatin Calcium; stomach pain from Ezetimibe Tablets. The severity of side effects can vary among individuals.

CHORD1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diabetes based on blood sugar or A1C levels.

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I am between 18 and 89 years old.

CHORD1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Light Transmission Aggregation (LTA) from Baseline

Change in Monocyte Platelet Aggregation (MPA) from Baseline

Secondary outcome measures

Percent Change in CD8 Cell Population from Baseline

Percent Change in Dendritic Cell Population from Baseline

Percent Change in Natural Killer (NK) Cell Population from Baseline

CHORD1 Trial Design

1Treatment groups

Experimental Treatment

Group I: 4-Week LDL-Cholesterol (LDL-C)-Reduction TreatmentExperimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-FDG

2010

Completed Phase 2

~660

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,372 Previous Clinical Trials

840,985 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,847 Previous Clinical Trials

47,818,401 Total Patients Enrolled

Ira Goldberg, MDPrincipal InvestigatorNYU Langone Health

Media Library

Atorvastatin Calcium Tablets (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT05641753 — Phase 4

Type 1 Diabetes Research Study Groups: 4-Week LDL-Cholesterol (LDL-C)-Reduction Treatment

Type 1 Diabetes Clinical Trial 2023: Atorvastatin Calcium Tablets Highlights & Side Effects. Trial Name: NCT05641753 — Phase 4

Atorvastatin Calcium Tablets (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05641753 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any way that I can become a part of this clinical trial?

"This medical trial is enrolling 125 people with Type 1 diabetes Mellitus, aged between 18 and 89. To qualify for enrollment, patients must meet a range of criteria such as minimum A1C level or random plasma glucose levels, LDL-C higher than 100mg/dl, diagnosis confirmed by two clinical team members and agreement to provide written consent. Additionally candidates must have had the condition diagnosed at least one year prior; verified via FPG ≥126 mg/dL (7.0 mmol/L), 2-h PG ≥200 mg/dL (11.1 mmol/L) during an OGTT or autoimmune markers like GAD"

Answered by AI

Is it feasible to enroll in this research project presently?

"At the present moment, this clinical trial is actively searching for patients to take part. It was initially posted on November 16th 2022 and underwent its most recent update on November 29th of the same year."

Answered by AI

Are there any age restrictions on participation in this experiment?

"To be eligible for this investigation, the patient must fall within the age bracket of 18-89. For participants younger than 18, there are 220 relevant clinical trials available; those over 65 have access to 931 alternate studies."

Answered by AI

What is the upper limit of enrollees for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research endeavour was initially posted on November 16th 2022 and has recently been revised on the 29th of the same month. 125 participants are sought from 3 distinct medical institutions."

Answered by AI