The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
ife GmbH, Clinic
Mainz, Rhineland-Palatinate, Germany
Nitrotyrosine
The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal
Time frame: Baseline, after 10 weeks, after 24 weeks
Skin blood flow
Change in skin blood flow during stimulation by a standardized meal
Time frame: Baseline, after 10 weeks, after 24 weeks
mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
Biomarkers of sub-clinical inflammation and cardiovascular risk: Change in Macrophage activation, MAPK/eNOS production levels, adiponectin and hsCRP (after test meal) from baseline to endpoint
Time frame: Baseline, after 10 weeks, after 24 weeks
Insulin
Change in Insulin and the ratio from baseline to endpoint
Time frame: Baseline, after 10 weeks, after 24 weeks
HbA1c
Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint
Time frame: Baseline, after 10 weeks, after 24 weeks
Fasting blood glucose
Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint
Time frame: Baseline, after 10 weeks, after 24 weeks
Hypoglycemic events
Incidence of hypoglycemia from baseline to endpoint
Time frame: Baseline, after 10 weeks, after 24 weeks
intact Proinsulin
Change in intact Proinsulin and the ratio from baseline to endpoint
Time frame: Baseline, after 10 weeks, after 24 weeks
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