Clinical Trials Directory

Trials / Completed

CompletedNCT01011062

Effect of Angiotensin Receptor Blockade on Insulin Resistance and Adipose Tissue Cytokines in Type 2 Diabetes

Effect of Acute Angiotensin Receptor Blockade on Insulin Resistance and Selected Cytokines in Adipose Tissue in Type 2 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Institute for Clinical and Experimental Medicine · Other Government
Sex
Male
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls. Hypothesis: Changes in adipocytokine concentrations and/or expressions and different reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be found in patients with type 2 diabetes compared to healthy subjects. A significant relationships between insulin sensitivity and selected adipokines and intracellular fat content and high energy phosphates in soleus muscle will be documented in healthy individuals, while no significant relation will be found in patients with type 2 diabetes.

Detailed description

10-15 patients with type 2 diabetes and 10-15 healthy control subjects will be examined on an outpatient basis. The following examination will be carried out in each subject after 12 hrs fasting: * Oral glucose tolerance test (75 g of glucose) (in healthy subjects to confirm the normal tolerance of glucose). * Evaluation of insulin secretion after 1 mg of glucagon i.v. * Hyperinsulinaemic (75 milly-international unit(mIU)/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue. * Hyperinsulinemic (75 mIU/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry after losartan 100 mg given in the evening and in the morning before the study. * Proton and phosphorus magnetic resonance spectroscopy. Before (0 min), at 30 min and in the end of studies c) and d) the blood samples will be taken and biopsies of subcutaneous abdominal adipose tissue will be done.

Conditions

Interventions

TypeNameDescription
PROCEDUREHyperinsulinaemiaHyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
DRUGLosartanAcute administration of losartan 200mg total prior to clamp
DRUGSalineInfusion of Saline as a volume control intervention

Timeline

Start date
2004-01-01
Primary completion
2007-10-01
Completion
2009-08-01
First posted
2009-11-11
Last updated
2013-10-18

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT01011062. Inclusion in this directory is not an endorsement.