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NCT Number: NCT01011062

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Center, Institute of Clinical and Experimental Medicine

Prague, 14021, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes treated with oral agents and/or diet
  • Healthy volunteers age- and sex-matched to type 2 diabetes, without any concomitant disease

Exclusion criteria

  • Type 2 Diabetes
  • treated with insulin
  • clinical evidence of atherosclerotic complications
  • advanced long-term diabetic complications (manifest nephropathy, proliferative retinopathy)
  • other internal disease
  • weight change >10% 3 months prior to study
  • Healthy volunteers
  • fulfilling the criteria of metabolic syndrome
  • weight change >10% 3 months prior to study

Treatment and study plan

Hyperinsulinaemia

Procedure

Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp

Losartan

Drug

Acute administration of losartan 200mg total prior to clamp

Saline

Drug

Infusion of Saline as a volume control intervention

Primary outcomes

  1. insulin sensitivity measured as glucose disposal during clamp

    Time frame: 4 hours

Secondary outcomes

  1. plasma adipokines and their expressions in SAT

    Time frame: at 0 and 240 min of the clamp

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Collaborators

  • Ministry of Health, Czech Republic

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Oct 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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