NCT01946347

Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

Effect of Hyperinsulinemia and Postprandial Metabolic Changes on Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institute for Clinical and Experimental Medicine · Other Government
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Insulin Resistance
• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	mixed meal	Baguette Cheese Gourmet (Crocodile: 180g, energy 452.8 Kcal, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.
OTHER	Acute in vivo induced hyperinsulinemia	Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2013-09-19
• Last updated: 2016-03-07

Locations

1 site across 1 country: Czechia