Cholesterol Lowering and Residual Risk in Diabetes, Type 1

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

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.

Drug: Evolocumab Cartridge
Injectable PCSK9 inhibitor.
Other Name: REPATHA
Drug: Atorvastatin Calcium Tablets
HMG-CoA reductase inhibitor for oral use.
Other Name: LIPITOR
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.
Other Name: ZETIA
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.
Other Name: BD Insyte Autoguard
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.

Source: View full study details on

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December 9, 2022Comments | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine