Cholesterol Lowering and Residual Risk in Diabetes, Type 1

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.

Conditions

• Type 1 Diabetes

Interventions

DRUG

Evolocumab Cartridge

Injectable PCSK9 inhibitor.

DRUG

Atorvastatin Calcium Tablets

HMG-CoA reductase inhibitor for oral use.

DRUG

Ezetimibe Tablets

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

DRUG

18F-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.

DEVICE

Angiocatheter 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.

DEVICE

J-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.

DEVICE

GlycoCheck Glycocalyx Measurement Software

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

Sponsors & Collaborators

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

  collaborator NIH

• NYU Langone Health

  lead OTHER

Principal Investigators

• Ira Goldberg, MD · NYU Langone Health

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-06

Primary Completion

2027-07-01

Completion

2027-07-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations