Cholesterol Lowering and Residual Risk in Diabetes, Type 1

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05641753
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab Cartridge — DRUG
    Injectable PCSK9 inhibitor.
  • Atorvastatin Calcium Tablets — DRUG
    HMG-CoA reductase inhibitor for oral use.
  • Ezetimibe Tablets — DRUG
    Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.
  • 18F-FDG — DRUG
    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.
  • Angiocatheter 20IV — DEVICE
    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.
  • J-Wire — DEVICE
    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.
  • GlycoCheck Glycocalyx Measurement Software — DEVICE
    Optional procedure (assessment of vascular function). Video microscope developed by GlycoCheck.

Study Details

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.

Key Dates

Start date
Dec 6, 2022
Status verified
Dec 2025
Primary completion
Jul 1, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Change in Monocyte Platelet Aggregation (MPA) from Baseline [ Time Frame: Baseline, Week 4 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mount Sinai School of MedicineNew YorkNew York10029
Zahi Fayad (PRINCIPAL_INVESTIGATOR)
New York VA HospitalNew YorkNew York10010-
NYC Health + Hospitals/BellevueNew YorkNew York10016-
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Mount Sinai School of Medicine· New York, NYNew York VA Hospital· New York, NYNYC Health + Hospitals/Bellevue· New York, NYNYU Langone Health· New York, NY

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