Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients - Full Text View

Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

This study has been completed.

Sponsored by:	University Medical Centre Ljubljana
Information provided by:	University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT00483392

Purpose

The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.

Condition	Intervention
Insulin Resistance	Drug: metformin, rosiglitazone

MedlinePlus related topics:

AIDS Metabolic Disorders

ChemIDplus related topics:

Insulin Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:

fasting plasma glucose, basal insulin levels [ Time Frame: 48 weeks ]

Secondary Outcome Measures:

insulin resistance, beta cell function [ Time Frame: 48 week ]

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male

Criteria

Inclusion Criteria:

documented HIV infection
stable Protease Inhibitor containing HAART regimen for at least 12 months
impaired glucose tolerance
elevated insulin levels (above 20 mIU/l)

Exclusion Criteria:

patients already taking oral hypoglycaemic treatment or insulin
heart failure NYHA I-IV
liver disease or kidney disease
elevated AST or ALT above 2 times upper normal range
elevated creatinine (above 150 mmol/l)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483392

Locations


Slovenia
	Department of Endocrinology, Diabetes and Metabolic diseases
	Ljubljana, Slovenia, 1525

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators


Study Chair:	Andrej Janez, MD, PhD	Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia

More Information

Publications indexed to this study:

Silic A, Janez A, Tomazic J, Karner P, Vidmar L, Sharma P, Maticic M. Effect of rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus receiving highly active antiretroviral therapy containing protease inhibitor: randomized prospective controlled clinical trial. Croat Med J. 2007 Dec;48(6):791-9.

Study ID Numbers:	J3-3545, Slovenia grant J3-3545
First Received:	June 5, 2007
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00483392
Health Authority:	Slovenia: Institutional Review Board

Keywords provided by University Medical Centre Ljubljana:

insulin

rosiglitazone

metformin

hiv

protease inhibitors

Study placed in the following topic categories:

Hyperinsulinism

Metabolic Diseases

Hyperglycemia

HIV Infections

Metformin

Acquired Immunodeficiency Syndrome

Insulin Resistance

Metabolic disorder

Glucose Metabolism Disorders

Rosiglitazone

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008