drugset / Trial / NCT05641753

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

NCT05641753

NaSingle-groupOpen-labelOther

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.

Timeline

Start
2022-12-06
Primary completion
2027-07-01
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 80 mg Oral
Subject Evolocumab Monoclonal antibody 140 mg Other
Subject Ezetimibe Unknown 10 mg Oral
Background 18F-FDG Diagnostic / imaging agent 7 unknown Other