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 ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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