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CompletedNCT01011062Updated Oct 18, 2013

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

An interventional study of Hyperinsulinaemia and Losartan in Insulin Resistance and Type 2 Diabetes, sponsored by Institute for Clinical and Experimental Medicine. Completed at 1 site in Czech Republic. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-18.

Sponsored by Institute for Clinical and Experimental Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Insulin Resistance
  • Type 2 Diabetes

Keywords

  • Adipose tissue
  • Adipokines
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 23 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Healthy volunteers

    • fulfilling the criteria of metabolic syndrome
    • weight change >10% 3 months prior to study
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Hyperinsulinaemia

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

    Procedure: Hyperinsulinaemia

  • Experimental
    Losartan + hyperinsulinaemia

    Procedure: Hyperinsulinaemia · Drug: Losartan

  • Placebo comparator
    Saline

    Infusion of Saline as a volume control intervention

    Drug: Saline

Interventions

  • ProcedureHyperinsulinaemia

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

  • DrugLosartan

    Acute administration of losartan 200mg total prior to clamp

  • DrugSaline

    Infusion of Saline as a volume control intervention

06

What researchers measure

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

07

Study locations

1 site
  • Diabetes Center, Institute of Clinical and Experimental Medicine
    Prague, 14021, Czech Republic
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01011062
Lead sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Ministry of Health, Czech Republic
First posted
Nov 11, 2009
Start date
Jan 2004
Primary completion
Oct 2007
Completion
Aug 2009
Last update
Oct 18, 2013

Study contacts

Terezie Pelikanova, Prof., MD
principal investigator · Diabetes Center, Institute of Clinical and Experimental Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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