Treatment of Hyperglycaemia and Insulin Resistance in HIV... | NCT00483392

Studies
Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

NCT00483392

Sponsor

University Medical Centre Ljubljana

Status

Completed

Last Update Posted

Jun 7, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Insulin Resistance

Interventions

metformin, rosiglitazone

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Slovenia grant J3-3545

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 5, 2007

First Submission Date that Met QC Criteria

Jun 5, 2007

First Posted Date

Jun 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2007

Last Update Posted Date

Jun 7, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
metformin, rosiglitazone	Drug

Measure	Description	Time Frame
fasting plasma glucose, basal insulin levels		48 weeks

Measure	Description	Time Frame
insulin resistance, beta cell function		48 week

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Diabetes and Metabolic diseases		Ljubljana	Ljubljana	1525	Slovenia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18074413	Derived	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. doi: 10.3325/cmj.2007.6.791.

ID	Term
D007333	Insulin Resistance
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases