Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
NCT ID: NCT02633488
Last Updated: 2020-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2014-06-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Placebo
12 weeks of Placebo tablet 3 x daily
Placebos
A 12 week single blind placebos
Metformin
12 weeks of Metformin tablet 850 mg 3 x daily
metformin
A 12 week single blind metformin
Interventions
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Placebos
A 12 week single blind placebos
metformin
A 12 week single blind metformin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No smoking the past 6 months
* Normal screening labs or no clinically significant values-except those listed below
* Must have 3 of the following 4 characteristics established by NCEP-AHA-NHLBI
* Males waist circumference greater than 40 inches, females greater than 35 inches
* Blood pressure greater than 130/85 or on treatment with one or more antihypertensive agent
* Fasting plasma triglycerides \>150 or HDL \<40 (males) \<50 (females)
* Fasting blood sugar \>100 but \<126
* Subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval.
* Ace inhibitor
* ARB
* HMG CoA reductase inhibitor
* Beta blocker
* Calcium channel blockers
* Alpha-adrenergic antagonist
Exclusion Criteria
* HbA1c ≥ 6.5
* Glucocorticoids-eg: prednisone, dexamethasone
* Any known sensitivity or intolerance to Metformin
* Any chronic GI disorders such as Irritable Bowel Syndrome or Crohns disease
* History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
* History of malignant or metabolic disorders including diabetes
* Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI)
* Hypersensitivity to perflutren (contained in Definity)
* Pregnant or breastfeeding
18 Years
60 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Eugene Barrett
MD PhD
Principal Investigators
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Eugene Barett, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Other Identifiers
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16121
Identifier Type: -
Identifier Source: org_study_id
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