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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UNKNOWN
PHASE2
12 participants
INTERVENTIONAL
2015-02-28
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin Treatment Arm
500 mg metformin Extended Release tablets - one tablet daily increased at 4 weeks to 2 tablets (1000 mg) daily.
metformin extended release
Observational Arm
Observation only
No interventions assigned to this group
Interventions
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metformin extended release
Eligibility Criteria
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Inclusion Criteria
* on suppressive ART stable for \> 1 year
* Age \> 45 years
* Ability and willingness to provide written informed consent
Exclusion Criteria
* Acute illness within 2 weeks of entry
* Diagnosis of diabetes or impaired fasting glucose
* Chronic diarrhea
* Known hypersensitivity or contraindication to metformin use
* Hepatitis C co-infection
* Serum B12 level below the reference normal range as listed by the commercial laboratory (Diagnostic Laboratory Services)
* Pregnancy, or intent to become pregnant
* Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
* Current or past history of coronary artery disease or congestive heart failure
* Resting heart rate \> 100 beats/min
* Presence of conduction abnormalities or pathologic arrhythmia on EKG
* The following lab values: Hemoglobin \< 9.0 g/dL; Absolute neutrophil count \< 1000/μL; Platelet count \< 50,000/μL; and AST (SGOT) and ALT (SGPT) \> 5x ULN
* Calculated creatinine clearance (Cockcroft and Gault) \< 60 ml/min
* Patients over 450 lbs
* History of iodine allergy or X-ray contrast allergy
* History of allergy to metoprolol
* Active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements
* Patients in whom there are other reasons that the CAC/CTA procedure is contra-indicated or who are at higher risk of adverse events
* Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable
45 Years
ALL
No
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
University of Hawaii
OTHER
Responsible Party
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Principal Investigators
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Cecilia M Shikuma, MD
Role: PRINCIPAL_INVESTIGATOR
University of Hawaii
Locations
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Hawaii Center for AIDS
Honolulu, Hawaii, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H028
Identifier Type: -
Identifier Source: org_study_id
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