NCT01011062

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

October 18, 2013

Status Verified

November 1, 2009

Enrollment Period

3.8 years

First QC Date

November 10, 2009

Last Update Submit

October 17, 2013

Conditions

Insulin ResistanceType 2 Diabetes

Keywords

Adipose tissueAdipokines

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity measured as glucose disposal during clamp

    4 hours

Secondary Outcomes (1)

  • plasma adipokines and their expressions in SAT

    at 0 and 240 min of the clamp

Study Arms (3)

Hyperinsulinaemia

EXPERIMENTAL

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

Procedure: Hyperinsulinaemia

Losartan + hyperinsulinaemia

EXPERIMENTAL
Procedure: HyperinsulinaemiaDrug: Losartan

Saline

PLACEBO COMPARATOR

Infusion of Saline as a volume control intervention

Drug: Saline

Interventions

HyperinsulinaemiaPROCEDURE

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

HyperinsulinaemiaLosartan + hyperinsulinaemia
LosartanDRUG

Acute administration of losartan 200mg total prior to clamp

Losartan + hyperinsulinaemia
SalineDRUG

Infusion of Saline as a volume control intervention

Saline

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Center, Institute of Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Interventions

LosartanSodium Chloride

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Terezie Pelikanova, Prof., MD

    Diabetes Center, Institute of Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

January 1, 2004

Primary Completion

October 1, 2007

Study Completion

August 1, 2009

Last Updated

October 18, 2013

Record last verified: 2009-11

Locations

CZ(1)