Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

Not Applicable

Completed

• Conditions: Insulin Resistance; Type 2 Diabetes
• Interventions: Other: mixed meal; Other: Acute in vivo induced hyperinsulinemia

• Registration Number: NCT01946347
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes	mixed meal	30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia
Patients with type 2 diabetes	Acute in vivo induced hyperinsulinemia	30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia
Healthy subjects	Acute in vivo induced hyperinsulinemia	30 healthy men and women with no metabolic syndrome Intervention: mixed meal, acute in vivo induced hyperinsulinemia
Healthy subjects	mixed meal	30 healthy men and women with no metabolic syndrome Intervention: mixed meal, acute in vivo induced hyperinsulinemia

Primary Outcome Measures

Name	Time	Method
Changes of endothelial function (measured by EndoPat)	120 minutes	at 0 and after 120 minutes during the clamp and 120 minutes after meal ingestion

Secondary Outcome Measures

Name	Time	Method
Changes in gastrointestinal peptides concentrations	180 minutes	0, 30, 60, 120, 180 minutes after meal ingestion
Changes in oxidative stress markers	120 minutes	at 0 and after 120 minutes after meal ingestion
Insulin sensitivity measured as glucose disposal during clamp	4 hours

Trial Locations

Locations (1)

Diabetes Center, Institute of Clinical and Experimental Medicine; 🇨🇿 Prague, Czech Republic