Insulin ResistanceNCT00483392
Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
A study testing metformin, rosiglitazone in people with Insulin Resistance, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- metformin, rosiglitazone
- How many people
- Not given
- Where
- 1 siteSlovenia
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Adult
Who may be able to join
- documented HIV infection
- stable Protease Inhibitor containing HAART regimen for at least 12 months
- impaired glucose tolerance
- elevated insulin levels (above 20 mIU/l)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department of Endocrinology, Diabetes and Metabolic diseases
Ljubljana, Ljubljana, 1525
About this study
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.
- Conditions
- Insulin Resistance
- Being tested
- metformin, rosiglitazone
- Keywords
- insulin, rosiglitazone, metformin, hiv, protease inhibitors
- Medical subject headings
- Insulin Resistance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin, rosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma glucose, basal insulin levels
Measured: 48 weeks
Secondary outcomes (1)
insulin resistance, beta cell function
Measured: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Investigators
- Andrej Janez, MD, PhD, Study chair, Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483392
- Sponsor's protocol ID
- J3-3545
- Other IDs
- Slovenia grant J3-3545
- Status last verified
- Jun 2007
- First submitted
- 5 Jun 2007
- Last updated
- 7 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18074413
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT00483392
- Acronym / sponsor ID
- J3-3545
- Conditions
- Insulin Resistance
- Keywords
- insulin, rosiglitazone, metformin, hiv, protease inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- First posted
- 7 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- documented HIV infection
- stable Protease Inhibitor containing HAART regimen for at least 12 months
- impaired glucose tolerance
- elevated insulin levels (above 20 mIU/l)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metformin, rosiglitazone | Drug | – |
Primary outcome
fasting plasma glucose, basal insulin levels
Time frame: 48 weeks
1 secondary outcome
insulin resistance, beta cell function
Time frame: 48 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2007.
- Derived from this study: PubMed 18074413Silic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Janez, MD, PhD study chair
Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metformin, rosiglitazone in people with Insulin Resistance, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting plasma glucose, basal insulin levels (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2007.