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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01011062
First received: November 10, 2009
Last updated: October 17, 2013
Last verified: November 2009

November 10, 2009
October 17, 2013
January 2004
October 2007   (final data collection date for primary outcome measure)
insulin sensitivity measured as glucose disposal during clamp [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011062 on ClinicalTrials.gov Archive Site
plasma adipokines and their expressions in SAT [ Time Frame: at 0 and 240 min of the clamp ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Insulin Resistance
  • Type 2 Diabetes
  • Procedure: Hyperinsulinaemia
    Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
  • Drug: Losartan
    Acute administration of losartan 200mg total prior to clamp
  • Drug: Saline
    Infusion of Saline as a volume control intervention
  • Experimental: Hyperinsulinaemia
    Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
    Intervention: Procedure: Hyperinsulinaemia
  • Experimental: Losartan + hyperinsulinaemia
    Interventions:
    • Procedure: Hyperinsulinaemia
    • Drug: Losartan
  • Placebo Comparator: Saline
    Infusion of Saline as a volume control intervention
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
August 2009
October 2007   (final data collection date for primary outcome measure)

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:

  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
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01011062
CDS01
Yes
Dagmar Köveslygetyova, Diabetes Center, Institute for Clinical and Experimental Medicine
Institute for Clinical and Experimental Medicine
Ministry of Health, Czech Republic
Principal Investigator: Terezie Pelikanova, Prof., MD Diabetes Center, Institute of Clinical and Experimental Medicine
Institute for Clinical and Experimental Medicine
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP