Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial

Table 1 Schedule of study assessments

	V1 (Baseline)	V2 (6 months)	V3 (12 months)	V4 (18 months)	V5 (24 months)
Informed consent	√
Medical history	√	√	√	√	√
Physical examination	√	√	√	√	√
Vital signs	√	√	√	√	√
Anthropometric measures	√		√		√
Blood tests
Complete blood count	√				√
Routine blood chemistry	√		√		√
Lipid profile	√		√		√
Fasting plasma glucose	√		√		√
Hemoglobin A1c	√		√		√
Insulin	√		√		√
C-peptide	√		√		√
HOMA-R	√		√		√
HOMA-β	√		√		√
Adiponectin	√		√		√
High-sensitivity CRP	√				√
Cardiac troponin I	√				√
Creatine kinase	√		√		√
Carotid ultrasound
Strain by B-mode	√		√		√
Stiffness by B-mode	√		√		√
Distensibility by B-mode	√		√		√
Strain by speckle tracking	√		√		√
Stiffness by speckle tracking	√		√		√
Echocardiography
2D measurements	√		√		√
M-mode parameters	√		√		√
Doppler parameters	√		√		√
Tissue Doppler parameters	√		√		√
2D speckle-tracking analysis	√		√		√
Clinical events	√	√	√	√	√

Abbreviations: HOMA-R Insulin resistance index of homeostasis model assessment, HOMA-β Secretory ability of homeostasis model assessment, CRP C-reactive protein, 2D Two-dimensional

ISSN: 1745-6215