Effect of Angiotensin Receptor Blockade on Insulin Resistance and Adipose Tissue Cytokines in Type 2 Diabetes
NCT ID: NCT01011062
Last Updated: 2013-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2004-01-31
2009-08-31
Brief Summary
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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
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* 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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Hyperinsulinaemia
Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
Hyperinsulinaemia
Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
Losartan + hyperinsulinaemia
Hyperinsulinaemia
Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
Losartan
Acute administration of losartan 200mg total prior to clamp
Saline
Infusion of Saline as a volume control intervention
Saline
Infusion of Saline as a volume control intervention
Interventions
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Hyperinsulinaemia
Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
Losartan
Acute administration of losartan 200mg total prior to clamp
Saline
Infusion of Saline as a volume control intervention
Eligibility Criteria
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Inclusion Criteria
2. Healthy volunteers age- and sex-matched to type 2 diabetes, without any concomitant disease
Exclusion Criteria
* 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
18 Years
70 Years
MALE
Yes
Sponsors
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Ministry of Health, Czech Republic
OTHER_GOV
Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Diabetes Center, Institute for Clinical and Experimental Medicine
Principal Investigators
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Terezie Pelikanova, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Diabetes Center, Institute of Clinical and Experimental Medicine
Locations
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Diabetes Center, Institute of Clinical and Experimental Medicine
Prague, , Czechia
Countries
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Other Identifiers
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CDS01
Identifier Type: -
Identifier Source: org_study_id