Type 2 Diabetes Clinical Trial
Official title:
Effect of Hyperinsulinemia and Postprandial Metabolic Changes on Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects
The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes
in plasma glucose and lipids concentrations on the endothelial function together with other
metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects.
Hypothesis:
Different changes in endothelial function to acute in vivo induced hyperinsulinemia and
after the meal test will be found in patients with T2D compared to healthy subjects.
A significant relationships between insulin sensitivity, selected adipokines
intramyocellular fat content, hepatic fat content and high energy phosphates in soleus
muscle will be documented in both groups.
30 patients with T2D and 30 healthy control subjects will be examined on an outpatient
basis. The following examination will be carried out in each subject after 12 hrs fasting:
- Hyperinsulinaemic euglycemic clamp study lasting 4 hours combined with indirect
calorimetry and biopsy of subcutaneous adipose tissue and muscle aspiration biopsy
- Meal test:Plasma glucose, immunoreactive insulin, plasma lipids, oxidative stress
markers and gastrointestinal peptides measured in response to a standard meal(at times
0´,30´,60´,120´,180´)
- At the beginning and after 120 minutes during the meal test and clamp peripheral
microvascular endothelial function will be measured using EndoPat(Itamar Medical)
- Proton and phosphorus magnetic resonance spectroscopy(MRS).
- Dual Energy X-ray Absorptiometry(DXA) scanning to measure body composition.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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