None listed
Conditions
Brief summary
The study will examine the hypothesis that higher doses of insulin chronically administered to patients with type 2 diabetes are associated with inflammation, oxidative stress and endothelial dysfunction. The study is observational, no intervention will be made on insulin treatment before or during the study.
Interventions
This cross-sectional study will examine the association between exogenous insulin dose and inflammation, oxidative stress and endothelin-1 in patients with insulin-treated type 2 diabetes. Measurement of markers of metabolic stress will be done as a single assessment at enrollment into the study. All biomarkers will be compared between patients into the first and third tertile of insulin doses. Mean levels of insulin dose/kg of body weight will be reported for each tertile.
After completion of
This cross-sectional study will examine the association between exogenous insulin dose and inflammation, oxidative stress and endothelin-1 in patients with insulin-treated type 2 diabetes. Measurement of markers of metabolic stress will be done as a single assessment at enrollment into the study. All biomarkers will be compared between patients into the first and third tertile of insulin doses. Mean levels of insulin dose/kg of body weight will be reported for each tertile. After completion of enrollment, participants will be divided into 3 equal groups based on ordered distribution of their insulin dose/kg of body weight (1st tertile, 2nd tertile and 3rd tertile). Tertile is defined as any of the two points that divide an ordered distribution into three parts, each containing a third of the population.
Sponsors
Cornelia Bala
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. adult (>=18 years) patients with type 2 diabetes, treated with insulin for at least 6 months; 2. stable insulin dose (+/- 10%) in the last 3 months; 3. patients who signed informed consent.
Exclusion criteria
type 1 and other specific types of diabetes including gestational diabetes; diabetic ketoacidosis and hyperglycemic-hyperosmolar state; acute illnesses able to influence current insulin doses; acute infections; ALAT and/or ALAT>3 ori upper normal limit, eGFR<30 ml/min/1,73 m2); antiinflammatory drugs, except aspirin<300 mg/day within the previous 3 months; pregnancy and lactation
Outcome results
None listed